Instructions Erbisol Ultrapharm solution for injection ampoule 2 ml No. 10
Composition
active ingredients: a complex of natural non-protein low-molecular organic compounds of non-hormonal origin, obtained from animal embryonic tissue, contains oligopeptides, glycopeptides, 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.
Antiviral agents for systemic use. ATX code J05.
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® ULTRApharm activates the immune system to accelerate the recovery of damaged and the destruction of abnormal cells and tissues. The main immunomodulatory effect of the drug is manifested, first of all, due to the effect on NK cells (CD3-/16+56+) and T-killers (CD3+/16+56+), which are responsible for the destruction of damaged cells that are not capable of regeneration, or abnormal cells (mutant, malignant, virus-carrying cells, etc.) and tissues, as well as through the macrophage link, which is responsible for the repair of damaged cells and the restoration of the functional activity of organs and tissues. At the same time, ERBISOL® ULTRApharm has an immunocorrective effect and, in case of immune status disorders, contributes to its normalization, activating T-lymphocytes, Th1-helpers and T-killers, which is important for restoring the balance between cellular and humoral immunity in cancer and allergic processes. Depending on the state of the body's immune system, the drug also corrects the level of some other immune factors: induces the synthesis of α-, b- and g-interferons, tumor necrosis factor, interleukin-2 (IL-2) and IL-12, inhibits the synthesis of IL-10. ERBISOL® ULTRApharm enhances the effect of antibiotics, exogenous interferons and, at the same time, reduces their toxic side effects.
In viral hepatitis, ERBISOL® ULTRApharm activates cytotoxic T-lymphocytes (CD8+) and T-killers (CD3+/16+56+), which are responsible for the destruction of virus-carrying cells, and also induces the synthesis of interferons, 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 ones, which allows ERBISOL® ULTRApharm to be attributed to drugs that reduce the severity of an infectious disease. The drug has anti-inflammatory properties, but the treatment of chronic inflammatory processes may go through an exacerbation phase for 2–5 days.
In cancer, ERBISOL® ULTRApharm helps to correct the immune system of patients, normalizing its parameters by activating 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 nonspecific immunity, induces the synthesis of a- and g-interferons and tumor necrosis factor. This can lead to inhibition of both the growth and metastasis of malignant tumors, and in combination with surgery or chemo- and radio-therapy can contribute to their effective destruction. As a support drug for chemo- and radio-therapy, ERBISOL® ULTRApharm significantly increases the effectiveness of treatment in two directions. Firstly, as a reparant and immunoprotector - it protects healthy cells and tissues from chemical and radiation damage, restoring damaged areas. This allows the use of more enhanced regimens with the use of potent chemotherapeutic agents and radiation doses without the risk of particularly negative consequences for the patient's condition, preventing hair loss, eliminating or significantly reducing the manifestations of vegetative, dyspeptic and pain syndromes, to maintain the patient's quality of life. Secondly, as an immunocorrector, the drug restores the antitumor functions of the immune system and, despite the damaging effects of chemo- and radiotherapy, contributes to the normalization of the immune status of patients after treatment. At the same time, ERBISOL® ULTRApharm, as a drug made from embryonic tissue, also exhibits the properties of a natural suppressor of abnormal growth of cells and tissues. This allows, unlike standard chemo- and radio-therapy, to mobilize the body's protective anti-tumor functions both during treatment and in the inter-course periods, which contributes to a further increase in their role and improvement of the quality of life of patients, as well as the possibility of reducing the number of courses of chemo- and radio-therapy.
The immunomodulatory effect begins to develop on the 3rd–5th day and reaches maximum values on the 20th–21st day, remaining at the same level for another 8–10 days after the end of the drug use. The drug is non-toxic, devoid of cumulative toxicity, teratogenic, mutagenic and carcinogenic properties.
Pharmacokinetics
Not studied.
Indication
Diseases of bacterial etiology - chronic nonspecific lung diseases during exacerbation and remission; diseases of viral etiology - acute and chronic viral hepatitis B, chronic viral hepatitis C; acute and chronic forms of diseases caused by viruses of the herpes family; oncology - gastrointestinal cancer, primary liver cancer and metastatic liver lesions, brain and lung tumors.
Contraindication
Individual intolerance to the drug.
Interaction with other medicinal products and other types of interactions
ERBISOL® ULTRApharm enhances the effect of antibacterial agents. For effective implementation of the directed immunomodulatory effect, ERBISOL® ULTRApharm should not be used together with alcohol (neutralizes the reparative effect of macrophages), and it is also not recommended to prescribe it with immunomodulators that stimulate humoral immunity.
Application features
This medicinal product contains less than 1 mmol (23 mg) sodium/dose, i.e. essentially sodium-free.
Ability to influence reaction speed when driving vehicles or other mechanisms
ERBISOL® ULTRApharm does not affect the reaction rate when driving or working with other mechanisms.
Use during pregnancy or breastfeeding
During pregnancy and breastfeeding, ERBISOL® ULTRApharm should be prescribed if, in the opinion of the doctor, the benefit of use outweighs the potential risk to the fetus/child.
Method of administration and doses
In the treatment of chronic nonspecific lung diseases, ERBISOL® ULTRApharm is administered intravenously to adults in a dose of 2 ml diluted with 0.9% sodium chloride solution to 20 ml as a jet in the evening daily for 10 days or intramuscularly in a dose of 2 ml in the evening daily for 20 days, or intramuscularly 2 times a day in the morning and evening daily for 10 days. The course dose is 10–20 ampoules of 2 ml.
During the period of exacerbation of the disease, it is used in complex therapy, and during the period of remission, the drug ERBISOL® ULTRApharm can be used independently.
In the treatment of diseases caused by herpes viruses, the drug ERBISOL® ULTRApharm is administered intravenously at a dose of 2 ml diluted with 0.9% sodium chloride solution to 20 ml as a jet in the evening every 48 hours for 20 days or intramuscularly at a dose of 2 ml in the evening daily for 20 days, or 2 ml 2 times a day in the morning and evening daily for 10 days. The course dose is 10–20 ampoules of 2 ml.
When internal organs and systems are affected by herpes viruses, the drug ERBISOL® ULTRApharm is administered intravenously at a dose of 2 ml diluted with 0.9% sodium chloride solution to 20 ml as a jet in the evening daily for 20 days, and then, to prevent relapses, for 20 days at a dose of 2 ml in the evening intramuscularly every 48 hours, or intramuscularly 2 times a day at a dose of 2 ml in the morning and evening daily for 20 days, and then, to prevent relapses, for 20 days at a dose of 2 ml in the evening intramuscularly every 48 hours. The course dose is 30–50 ampoules of 2 ml.
In the acute period of the disease, it is used in complex therapy, and during the period of remission, the drug ERBISOL® ULTRApharm can be used independently.
In complex therapy of acute viral hepatitis B, the drug ERBISOL® ULTRApharm is administered intravenously in a dose of 2 ml diluted with 0.9% sodium chloride solution to 20 ml jet in the evening daily for 20 days, and then for 20 days in the evening 2 ml intramuscularly every 48 hours, or intramuscularly in a dose of 2 ml 2 times a day in the morning and evening daily for 20 days, and then for 20 days in the evening 2 ml intramuscularly every 48 hours. The course dose is 30–50 ampoules of 2 ml.
In the complex therapy of chronic viral hepatitis C and B, the drug ERBISOL® ULTRApharm is administered intravenously at a dose of 2 ml diluted with 0.9% sodium chloride solution to 20 ml as a jet in the evening daily for 20 days or intramuscularly 2 times at a dose of 2 ml in the morning and evening daily for 20 days, and then at a dose of 2 ml in the evening intramuscularly every 48 hours for 20 days. The course dose is 30–50 ampoules of 2 ml.
After a 40–60-day break, it is necessary to conduct repeated courses of treatment, the number of which is determined by the severity of the pathological process.
Immunotherapy courses are combined with standard antitumor therapy courses. In this case, the drug ERBISOL® ULTRApharm is administered intravenously drip 6 ml, diluted with 0.9% sodium chloride solution to 200 ml, daily, first for 5 days, then after a 2-day break - 4 days, then after a 3-day break, during which chemotherapy is prescribed (•), continue in the same way for another 3 days, and on the 4th and 5th days, 4 ml of ERBISOL® ULTRApharm is administered, diluted with 0.9% sodium chloride solution to 200 ml (simplified scheme).
Combination with radiotherapy is possible. Course dose - 40 ampoules of 2 ml.
After a 2–6-day break, a second course of such therapy can be conducted.
The full course of therapy involves the administration of the drug in 4–7 cycles, each of which includes a 5-day daily administration of the drug and a 2-day break: intravenous drip 6 ml, diluted with 0.9% sodium chloride solution to 200 ml daily for 5 days, then a 2-day break, during which, in complex use together with chemotherapy, chemotherapy drugs are prescribed, continuing in the same way for the next 3–6 cycles. The course dose is 60–110 ampoules of 2 ml.
When administered intramuscularly, ERBISOL® ULTRApharm is administered 2 times a day, 4 ml in the morning and evening, daily for 5 days, then after a 2-day break, during which chemotherapy is administered, the same procedure is continued for the next 3–5 cycles. The course dose is 80–140 ampoules of 2 ml.
Upon completion of the course of combination therapy after a 2–4-day break, it is advisable to conduct a course of immunotherapy, in which the drug ERBISOL® ULTRApharm is administered intramuscularly 2 times a day, 2 ml in the morning and evening daily for 5 days, then after a 2-day break, the same procedure is continued for another 5 days. The course dose is 10–20 ampoules of 2 ml.
If chemotherapy courses do not involve the administration of hormones or drugs that affect the patient's hormonal status, then courses of the drug ERBISOL® ULTRApharm are combined with chemotherapy courses and are prescribed 1–2 hours after the administration of chemotherapy drugs, preferably intravenously drip. In chemotherapy of brain tumors, 5-day courses of the drug temozolid are combined with 5-day cycles of administration of the drug ERBISOL® ULTRApharm.
In radio-radiation therapy, 5-day cycles of irradiation can be performed together with 5-day cycles of administration of the drug ERBISOL® ULTRApharm, separating them from each other by an interval of at least 3 hours.
It is advisable to administer ERBISOL® ULTRApharm injections on an empty stomach, i.e. in the morning 1–2 hours before a meal or in the evening 2–3 hours after. Tea, juices, water, etc. can be consumed at any time.
Children
There is no experience in children (under 18 years of age).
Overdose
There is no experience in children (under 18 years of age).
Adverse reactions
ERBISOL® ULTRAfarm is well tolerated by patients without allergic reactions. However, in some cases, during the first 2–5 days of administration, the drug may cause exacerbation of the chronic inflammatory process, which should not be considered a negative phenomenon, since in most cases it is a stage of the treatment process. During clinical trials, as well as during the use of the drug in clinical practice, allergic reactions were not observed, but the risk of their development is not completely excluded, namely: skin rashes, itching.
When using a course of intensive therapy with intravenous drip administration of the drug ERBISOL® ULTRAfarm in the first days of administration, an increase in blood pressure and body temperature is possible, which should be reduced to normal. If the patient's condition is severe and the body temperature continues to rise, then the next 5-day cycle should be carried out with intramuscular administration of the drug (2 times a day, 4 ml in the morning and evening daily for 5 days).
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.
During storage, opalescence may occur.
Incompatibility
Do not mix with other medicinal products when administered. When diluting, use only the solutions specified in the section "Method of administration and dosage".
Packaging
10 ampoules of 2 ml in a cardboard box.
Vacation category
According to the recipe.
Producer
LLC “ERBIS”, PE “ERBIS Laboratory”.
Location of the manufacturer and its business address
Ukraine, 02002, Kyiv, R. Okipnoi St. 10-B, office 92.
