Immunomodulator L03A X,
Antiviral for systemic use J05

Immunomodulator L03A X, Antiviral for systemic use J05

APPROVED

                           Order of Ministry of Public

Health  of Ukraine

                        01.09.16   919

                                    Registration certificate

                      UA/3030/01/01  

                                                                                                          

INSTRUCTION

for medical using the medication

ERBISOL® ULTRApharm

Composition:

active substances: a complex of the natural protein-free low-molecular organic compounds of nonhormonal origin, obtained from the animal embryonic tissue, contains oligopeptides, glycopeptides, nucleotides and  aminoacids;

adjuvant substances: isotonic solution of 0.9 % sodium chloride.

Medicinal form.  Solution  for injections.          

Main physical and chemical properties: a transparent or slightly opalescent colorless or light yellow liquid with a specific odor.

Pharmacotherapeutical group.

Immunostimulators.                                 Code ATC L03A X.

Antiviral agents for systemic use.            Code ATC J05.

Pharmacological characteristics.

Pharmacodynamics. Pharmacological activity of the medication is determined by the content of low-molecular biologically active peptides, activizing the natural evolutionally formed controlling systems of the organism, responsible for the search and the elimination of pathological changes. ERBISOL® ULTRApharm activizes the immune system for the accelerated restoration of the damaged cells, and the elimination of abnormal cells and tissues. The principal immunomodulating effect of the medication is first of all manifested by its effect on the NK-cells (CD316+56+), and T-killers (CD3+16+56+), which are responsible for the destruction of damaged cells, incapable for the regeneration, or the abnormal cells (mutant, malignant, virus carrying cells etc.) and tissues, and also by macrophage link, responsible for repairing the damaged cells and the restoration of functional activity in the organs and the tissues. At the same time, ERBISOL® ULTRApharm has the immunocorrecting effect and promotes the normalization of disturbed immunologic status by activizing T-lymphocytes, Th1-helpers and T-killers that is important for the balance recovery between cellular and humoral immunity in oncologic and allergic processes. Depending on the body immune system, the level of some other factors of immunity is corrected by the medication: it induces the synthesis of α-, β-, γ-interferons, tumour necrosis factor, interleukin-2 (IL-2) and IL-12, inhibits synthesis of IL-10. ERBISOL® ULTRApharm potentiates the effect of antibiotics, exogenous interferons and decreases their toxic side effect at the same time.

In viral hepatitis ERBISOL® ULTRApharm activizes the cytotoxic T-lymphocytes (CD8+) and T-killers (CD3+16+56+), responsible for the destruction of the virus carrier cells and also induces the synthesis of interferons that contributes to the accelerated virus elimination. At the same time, activizing the hepatic regenerative processes, the medication promotes the substitution of dead hepatocytes by healthy ones, that allows to add ERBISOL® ULTRApharm to the medications, decreasing the severity degree of infectious disease. The medication has the antiinflammatory properties, however the treatment of chronic inflammatory processes can be passed without the phase of exacerbation for 2-5 days.

In oncologic diseases, ERBISOL® ULTRApharm contributes to the correction of the patient immune system, normalizing its parameters by activization of Th1-helpers and T-killers, and inhibition of the activity of Th2-helpers and B-lymphocytes, that promotes the restoration of specific cellular immunity and first of all the activization of T-killers. The medication activizes also macrophages and natural killers (N-killers) of unspecific immunity, induces the synthesis of α- and γ-interferons and tumour necrosis factor. This can lead to inhibition of the growth as well as metastasis of malignant tumours, and in a complex with surgical intervention or chemo- and radiotherapy, contribute to their effective destruction. As the acompanying medication, ERBISOL® ULTRApharm significantly increases the efficacy of treatment in two directions in 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 potent chemical substances 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 manifestation 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 after the therapy up to the parameters of the healthy persons, despite a damaging effect of chemo- and radiotherapy. In the same time, ERBISOL® ULTRApharm as the medication produced from embryonic tissue, also exhibits the properties of a natural cytostatic which inhibits the abnormal growth of cells and tissues. 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 promotes their subsequent increased role, and an improvement of the patient living standard and also the possible substitution of some chemo- and radiotherapy courses by the courses of immunotherapy and immunocorrection with ERBISOL® ULTRApharm, in contrast to the standard chemo- and radiotherapy.

The immunomodulating effect begins to develop at the days 3-5 of the therapy and the maximum values are reached at the 20th-21st days, maintaining at the same level for another 8-10 days after the end of the medication use.

The medication is nontoxic, without the cumulative toxicity, allergenic, teratogenic, mutagenic and carcinogenic properties.

Pharmacokinetics.  It was not studied.

Clinical characteristics.

Indications

– diseases of  bacterial etiology – chronic nonspecific lung diseases during the exacerbation and remission  periods;

– diseases of  viral etiology acute and chronic viral hepatitis B, chronic viral hepatitis С; acute and chronic forms of diseases,  induced by viruses of herpes family;

oncology oncologic diseases of the gastrointestinal tract, primary carcinoma of the liver and metastatic lesions of the liver, tumors of the brain and the lungs.

Contraindications.  Individual intolerance.

Interaction with other medications and other types of interactions. ERBISOL® ULTRApharm potentiates an effect of antibacterial remedies. For an effective realization of the directed immunomodulating effect, ERBISOL® ULTRApharm should not be used with alcohol (it neutralizes the reparation effect of macrophages), and it is also not recommended to prescribe with immunomodulators stimulating humoral immunity.

Peculiarities of use

Use in pregnancy or lactation periods

In pregnancy and lactation periods, ERBISOL® ULTRApharm should be prescribed in a case when a benefit of its use exceeds the potential harm for fetus/child to a doctor opinion.

Ability for influence on reaction rate while driving the motor transport or operating other machinery.

ERBISOL® ULTRApharm does not influence on a reaction rate while driving motor transport or operating other machinery.

Method of use and doses

ERBISOL® ULTRApharm is administered intramuscularly, intravenously, intraarterially or intraperitonealy at a dose of 2-10 ml every day and, taking into account the body chronorhythms, a single administration is advisable to prescribe in the evening at 21-24 hrs in 2-3 hrs after meals, and in a case of double administration an additional prescription is recommended at 6-9 hrs 1-2 hrs before meals.  

In therapy of chronic nonspecific pulmonary diseases ERBISOL® ULTRApharm, diluted with isotonic solution of 0.9 % sodium chloride up to 20 ml, is streamed intravenously administered at a dose of 2 ml, every day for 10 days or intramuscularly at a dose of 2 ml in the evening every day for 20 days, or intramuscularly at a dose of 2 ml twice a day in the morning and in the evening every day for 10 days. A course dose consists of 10-20 ampules per 2 ml.

A complex therapy is used in the period of disease exacerbation, and ERBISOL® ULTRApharm is used as monotherapy during the remission.

In therapy of diseases, induced by herpes family viruses (types I and II), ERBISOL® ULTRApharm, diluted with isotonic solution of 0.9 % sodium chloride up to 20 ml is streamed intravenously administered at a dose of 2 ml, every day for 10 days or intramuscularly at a dose of 2 ml every day in the evening for 20 days, or intramuscularly at a dose of 2 ml twice a day in the morning and in the evening for 10 days every day. A course dose is 10-20 ampules per 2 ml.

When the internal organs and systems are infected with viruses of herpes family, the medication ERBISOL® ULTRApharm, diluted with isotonic solution of 0.9 % sodium chloride up to 20 ml, is streamed intravenously administered at a dose of 2 ml for 20 days every day, or intramuscularly at a dose of 2 ml twice a day in the morning and in the evening for 20 days every day. Then the medication is prescribed after every 30-40 day intervals for preventing the relapses, and it is intramuscularly administered at a dose of 2 ml in the evening with following 1-3 time repetition. A course dose is 30-70 ampules per 2 ml.

In an acute period of disease the medication is used as part of complex therapy and the medication ERBISOL® ULTRApharm is used as monotherapy in the remission period.

In complex therapy of acute viral hepatitis B ERBISOL® ULTRApharm, diluted with isotonic solution of 0.9 % sodium chloride up to 20 ml, is streamed intravenously administered at a dose of    2 ml for 20 days every day, or intramuscularly at a dose of 2 ml twice a day in the morning and in the evening for 20 days every day, against a background of basis disintoxication therapy. A course dose is 20-40 ampules per 2 ml.

In complex therapy of chronic viral hepatitis C and B ERBISOL® ULTRApharm, diluted with isotonic solution of 0.9 % sodium chloride up to 20 ml, is streamed intravenously administered at a dose of 2 ml, for 20 days, or intramuscularly at a dose of 2 ml twice a day in the morning and in the evening for 20 days every day, against a background of basis disintoxication therapy. A course dose is 20-40 ampules per 2 ml.

After 40-60 day intervals it is necessary to repeat the courses of treatment, which number is determined by the severity of disease.

In oncologic diseases, the  courses of immunotherapy are used between the courses of chemio- or radiation therapy when ERBISOL® ULTRApharm is administered by 4 cycles (subcourses), every of which includes 5 day administrations of the medication with 2 day interval, while the administration of chemical substances can be prescribed as follows: an intravenous streamed injections of the medication, diluted with isotonic solution of  0.9 % sodium chloride up to 20 ml at a dose of 2 ml, for 5 days every day, then the next cycles (subcourses) are continued after 2 day interval by the same way or intramuscularly twice a day at a dose of 2 ml in the morning and in the evening for 5 days every day, then the next cycles (subcourses) are continued after 2 day intervals by the same way. A course dose is 20-40 ampules per 2 ml.

The courses of immunotherapy have to be combined with those of standard antitumour therapy. In this case ERBISOL® ULTRApharm, diluted with solution of 0.9 % sodium chloride up to 20 ml, is intravenously drop-by-drop administered at a dose of 6 ml, every day in the beginning for 5 days, then 4 days after 2 day intervals, and the administration is continued after 3 day intervals by the same way with an additional 3 days and at the 4th and the 5th days ERBISOL® ULTRApharm, diluted with solution of 0.9 % sodium chloride up to 200 ml (simplified scheme), is administered at a dose of 4 ml. It can be combined with chemo- (•) and radiation therapy. A course dose is 40 ampules per 2 ml.

A course of such therapy can be repeated after 2-6-day intervals.

 

Simplified scheme (minimum course) of oncologic disease therapy

when the medication is intravenously administered

(in a complex with chemotherapy (•) or radiotherapy)

A complete scheme of the intensive therapy course supposes the medication administration by 4-7 cycles, every of which includes 5-day administration of the medication every day with 2 day intervals:  intravenously drop-by-drop at a dose of 6 ml diluted by a solution of 0.9 % sodium chloride up to 200 ml every day for 5 days, then after 2 day intervals the administration of the next 3-6 cycles is continued by the same way. A course dose is 60-150 ampules per 2 ml.

ERBISOL® ULTRApharm is injected at a dose of 4-6 ml twice a day in the morning and in the evening for 5 days every day, then the administration of the next 3-6 cycles is continued after 2 day intervals by the same way, when administered intramuscularly. A course dose is 80-170 ampules per 2 ml. The courses of intensive therapy can also be used as monotherapy.

                       

Complete scheme of intensive therapy course for oncological diseases  

when the medication is intramuscularly (2u) and intravenously (3u) administered

(monotherapy, as well as in a complex with chemotherapy (•) or radiotherapy)

If chemotherapeutical courses do not provide the administration of hormones or agents influencing on patient hormonal status, the courses of ERBISOL® ULTRApharm as natural cytostatic can be combined with the chemotherapeutical courses and prescribe in 1-2 hours after the chemical substance administration, and an intravenous drop-by-drop administration is desirable. In a case of chemotherapy using substances effecting on patient hormonal status ERBISOL® ULTRApharm is prescribed no earlier than 3 hours after taking such substances

The 5 day courses of chemical substance temosolomide are combined with the 5 day cycles of the medication ERBISOL® ULTRApharm in chemotherapy of brain tumors.

The 5 day cycles of radiation therapy can be used in a complex with the 5 day cycles of the medication ERBISOL® ULTRApharm administration, delimiting them among themselves not less than 3 hour interval in radiotherapy.

The injections of ERBISOL® ULTRApharm are desirable to perform 1-2 hours before meals or in 2-3 hours after it. This is due to the fact that a desintoxication function of macrophages should not “divert” their participation in the immunological reactions and reparation processes. Tea, juices, water etc. can drink at any time.  

Children

Children under 18 years of age have no experience of use.

Overdosage

The short-term fatiguability can be occurred, without requiring specific therapy.

Side reactions                     

ERBISOL® ULTRApharm is well tolerated in patients without a manifestation of allergic reactions. However, an exacerbation of chronic inflammatory process which can not be considered as negative phenomenon, as it is a stage of treatment process in the majority of  cases, can be induced by the medication administration in some cases during the first 2-5 days of the therapy. Аllergic reactions were nоt noted in the process of clinical trials and its use in clinical practice, but a risk of their manifestations as dermal eruptions and pruritis was not completely excluded.

The increased arterial pressure and body temperature, that should be normalized, can be occurred in the intensive therapy course with intravenous drop-by-drop administration of the medication ERBISOL® ULTRApharm at first days. If the patient state is severe and the temperature continues to rise, the next 5 day cycle should be used with an intramuscular administration of the medication (twice a day at a dose of 4 ml in the morning and in the evening for 5 days every day). In this connection the first 5 day cycle of a course is recommended to conduct at a dose of 4 ml in the morning and in the evening every day intramuscularly twice a day.  

Shelf-life is 5 years.

Don’t use it 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 children reach. An  opalescence appearance is  permissible during storage.

Incompatibility. Do not mix when administered with other medicines. For dilution, use only the solvents specified in the section “Method of use and dosage”.

Packing. 10 ampules per 1 ml or  2 ml.

Distribution.  According to prescription.

Manufacturers. Scientific-Production Centre “ERBIS” Ltd.

PE “ERBIS Laboratory”

E-mail:  erbis@ukr.net

Web site: www.erbisol.com.ua

Location.  Ukraine, 02002,   Kiev, R. Okipnaya Str., 10b

tel:  +38 (044) 456-70-13; 569-70-14; 569-70-12;   592-37-77.