Erbisol ultapharm

INSTRUCTION for medical use of the medicinal product ERBISOL® ULTRApharm

Composition:

Active substances: a complex of natural non-protein low-molecular-weight organic compounds of non-hormonal origin obtained from animal embryonic tissue, containing oligopeptides, glycopeptides, nucleotides, amino acids;

Excipients: 0.9% isotonic sodium chloride solution.

Medicinal form. Injection solution.

Main physicochemical characteristics: clear or slightly opalescent, colorless or light yellow liquid with a specific odor.

Pharmacotherapeutic group.

Immunostimulants. ATC code L03A X.

Antiviral agents for systemic use. ATC code J05.

Pharmacological Properties

Pharmacodynamics. The pharmacological activity of the medicinal product is determined by the content of low-molecular-weight biologically active peptides that activate the body's natural, evolutionarily formed regulatory systems responsible for detecting and eliminating pathological changes. ERBISOL® ULTRAPHARM activates the immune system to accelerate the recovery of damaged cells and tissues and to destroy abnormal cells. The main immunomodulatory effect of the drug is primarily due to its action on NK cells (CD3-/16+56+) and T-killers (CD3+/16+56+), which are responsible for destroying damaged cells incapable of regeneration, or abnormal cells (mutant, malignant, virus-infected cells, etc.) and tissues. It also acts via the macrophage link, which is responsible for repairing damaged cells and restoring functional activity of organs and tissues. At the same time, ERBISOL® ULTRAPHARM exerts an immunocorrective effect in cases of immune status disorders, promoting its normalization by activating T-lymphocytes, Th1-helpers, and T-killers, which is important for restoring the balance between cellular and humoral immunity in oncological diseases and allergic processes. Depending on the state of the body's immune system, the drug modulates the levels of certain other immune factors: it induces the synthesis of α-, β-, and γ-interferons, tumor necrosis factor, interleukin-2 (IL-2), and IL-12, while suppressing the synthesis of IL-10. ERBISOL® ULTRAPHARM enhances the effects of antibiotics and exogenous interferons, while simultaneously reducing their toxic side effects.

In viral hepatitis, ERBISOL® ULTRAPHARM activates cytotoxic T-lymphocytes (CD8+) and T-killers (CD3+/16+56+) responsible for destroying virus-infected cells, and also induces interferon synthesis, promoting faster viral elimination. At the same time, by stimulating liver regeneration processes, the drug facilitates the replacement of dead hepatocytes with healthy ones, allowing ERBISOL® ULTRAPHARM to be classified among agents that reduce the severity of infectious disease. The drug has anti-inflammatory properties, but treatment of chronic inflammatory processes may involve an initial exacerbation phase lasting 2–5 days.

In oncological diseases, ERBISOL® ULTRAPHARM helps correct the immune system of patients by normalizing its parameters through activation of Th1-helpers and T-killers and inhibition of Th2-helpers and B-lymphocytes, thereby promoting restoration of specific cellular immunity, particularly activation of T-killers. The medicinal product also activates macrophages and natural killers (NK cells) of nonspecific immunity, induces synthesis of α- and γ-interferons and tumor necrosis factor. This may lead to inhibition of both growth and metastasis of malignant tumors, and in combination with surgical intervention or chemotherapy and radiation therapy, may contribute to their effective destruction. As a supportive agent during chemotherapy and radiation therapy, ERBISOL® ULTRAPHARM significantly increases treatment efficacy in two main ways. First, as a reparative and immunoprotective agent, it protects healthy cells and tissues from chemical and radiation damage and promotes recovery of injured areas. This allows the use of intensified treatment regimens with potent chemotherapeutic agents and higher radiation doses without risk of particularly adverse consequences for patients, preventing hair loss and eliminating or substantially reducing symptoms of vegetative, dyspeptic, and pain syndromes, thereby supporting the patient's quality of life. Second, as an immunocorrective agent, it restores antitumor functions of the immune system and, despite the damaging effects of chemotherapy and radiation therapy, promotes normalization of the patient’s immune status after treatment. At the same time, ERBISOL® ULTRAPHARM, being derived from embryonic tissue, also exhibits properties of a natural suppressor of abnormal cell and tissue growth. This enables, in contrast to standard chemotherapy and radiation therapy, mobilization of the body's natural antitumor defense mechanisms both during treatment and in inter-cycle periods, thereby enhancing their role over time, improving patients’ quality of life, and potentially reducing the number of chemotherapy and radiation therapy courses required.

The immunomodulatory effect begins to develop on days 3–5, reaches maximum levels by days 20–21, and remains at this level for an additional 8–10 days after discontinuation of the drug. The drug is non-toxic, lacks cumulative toxicity, and has no teratogenic, mutagenic, or carcinogenic properties.

Pharmacokinetics. Not studied.

Clinical characteristics.

Indications.

• Diseases of bacterial etiology – chronic nonspecific lung diseases during exacerbation and remission periods;
• diseases of viral etiology – acute and chronic viral hepatitis B, chronic viral hepatitis C; acute and chronic forms of diseases caused by herpesviruses;
• oncology – gastrointestinal tract cancers, primary liver cancer and metastatic liver lesions, brain and lung tumors.

Contraindications.

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 realization of targeted immunomodulatory action, ERBISOL® ULTRApharm should not be used together with alcohol (alcohol neutralizes the reparative function of macrophages). It is also not recommended to administer concomitantly with immunomodulators that stimulate humoral immunity.

Special precautions for use

This medicinal product contains less than 1 mmol (23 mg)/dose of sodium, i.e. it is practically sodium-free.

Use during pregnancy or breastfeeding.

ERBIOSOL® ULTRAFarm should be administered during pregnancy and breastfeeding only if, in the opinion of the physician, the benefit outweighs the potential risk to the fetus/child.

Ability to affect reaction speed when driving or operating machinery.

ERBIOSOL® ULTRAFarm does not affect reaction speed when driving or operating machinery.

Administration and Dosage

For the treatment of chronic nonspecific lung diseases, ERBISOL® ULTRAPHARM is administered intravenously to adults as 2 ml diluted in 0.9% sodium chloride solution to a volume of 20 ml, given as a slow bolus infusion in the evening daily for 10 days, or intramuscularly as 2 ml in the evening daily for 20 days, or intramuscularly twice daily (morning and evening) 2 ml each time for 10 days. Total course dose — 10–20 vials of 2 ml.

During disease exacerbation, the drug is used as part of combination therapy; during remission, ERBISOL® ULTRAPHARM may be used as monotherapy.

For the treatment of diseases caused by herpesviridae viruses, ERBISOL® ULTRAPHARM is administered intravenously as 2 ml diluted in 0.9% sodium chloride solution to a volume of 20 ml, given as a slow bolus infusion every 48 hours in the evening for 20 days, or intramuscularly as 2 ml in the evening daily for 20 days, or twice daily (morning and evening) 2 ml each time for 10 days. Total course dose — 10–20 vials of 2 ml.

In cases of internal organs and systems affected by herpesviridae viruses, ERBISOL® ULTRAPHARM is administered intravenously as 2 ml diluted in 0.9% sodium chloride solution to a volume of 20 ml, given as a slow bolus infusion in the evening daily for 20 days, followed by prophylaxis of relapses: intramuscularly 2 ml in the evening every 48 hours for 20 days; alternatively, intramuscularly twice daily (morning and evening) 2 ml each time for 20 days, followed by intramuscular administration of 2 ml in the evening every 48 hours for 20 days. Total course dose — 30–50 vials of 2 ml.

During the acute phase of the disease, the drug should be used as part of combination therapy; during remission, ERBISOL® ULTRAPHARM may be used as monotherapy.

For combination therapy of acute viral hepatitis B, ERBISOL® ULTRAPHARM is administered intravenously as 2 ml diluted in 0.9% sodium chloride solution to a volume of 20 ml, given as a slow bolus infusion in the evening daily for 20 days, followed by intramuscular administration of 2 ml in the evening every 48 hours for 20 days; alternatively, intramuscularly twice daily (morning and evening) 2 ml each time for 20 days, followed by intramuscular administration of 2 ml in the evening every 48 hours for 20 days. Total course dose — 30–50 vials of 2 ml.

For combination therapy of chronic viral hepatitis C and B, ERBISOL® ULTRAPHARM is administered intravenously as 2 ml diluted in 0.9% sodium chloride solution to a volume of 20 ml, given as a slow bolus infusion in the evening daily for 20 days, or intramuscularly twice daily (morning and evening) 2 ml each time for 20 days, followed by intramuscular administration of 2 ml in the evening every 48 hours for 20 days. Total course dose — 30–50 vials of 2 ml.

After a 40–60-day break, repeated treatment courses should be performed; the number of courses depends on the severity of the pathological process.

For oncological diseases, immunotherapy courses are administered between cycles of chemotherapy or radiation therapy. The treatment consists of 4 cycles (sub-courses), each including 5 consecutive days of daily drug administration followed by a 2-day break, during which chemotherapy is administered: intravenously 2 ml diluted in 0.9% sodium chloride solution to 20 ml as a slow bolus infusion daily for 5 days, then after a 2-day break, continue with the next cycles (sub-courses) in the same manner; or intramuscularly twice daily (morning and evening) 2 ml each time for 5 days, then after a 2-day break, continue with the next cycles (sub-courses) in the same manner. Total course dose — 20–40 vials of 2 ml.

Immunotherapy courses are combined with standard anti-tumor therapy courses. In this case, ERBISOL® ULTRAPHARM is administered intravenously by drip infusion: 6 ml diluted in 0.9% sodium chloride solution to 200 ml, daily — initially for 5 days, then after a 2-day break for 4 days, then after a 3-day break (during which chemotherapy (•) is administered), continue in the same manner for another 3 days, and on the 4th and 5th days administer 4 ml of ERBISOL® ULTRAPHARM diluted in 0.9% sodium chloride solution to 200 ml (simplified regimen).

Combination with radiation therapy is possible. Total course dose — 40 vials of 2 ml.

After a 2–6-day break, a repeated course of this therapy may be administered.

Simplified regimen (minimal course) for oncological disease treatment
with intravenous administration of the drug
(in combination with chemotherapy (•) or radiation therapy)

• • •

| 3 days | 5 days | 2 days | 4 days | 3 days | 5 days | 3 days |

Complete treatment regimen involves administration of the drug in 4–7 cycles, each including 5 consecutive daily administrations followed by a 2-day break: intravenous infusion of 6 ml diluted in 0.9% sodium chloride solution to a total volume of 200 ml daily for 5 days, then a 2-day break, during which, as part of combination therapy with chemotherapy, chemotherapeutic agents are administered; then continue with 3–6 subsequent cycles in the same manner. Total course dose – 60–110 vials of 2 ml.

For intramuscular administration, ERBISOL® ULTRApharm is administered twice daily (4 ml in the morning and 4 ml in the evening) daily for 5 days, followed by a 2-day break, during which chemotherapeutic agents are administered; then continue with 3–5 subsequent cycles in the same manner. Total course dose – 80–140 vials of 2 ml.

After completion of the combined therapy course, following a 2–4-day break, it is advisable to conduct an immunotherapy course, during which the medicinal product ERBISOL® ULTRApharm is administered intramuscularly twice daily (2 ml in the morning and 2 ml in the evening) daily for 5 days, followed by a 2-day break, then continue for another 5 days in the same manner. Total course dose – 10–20 vials of 2 ml.

Complete treatment regimen for oncological diseases

with intravenous administration of the drug

(in combination with chemotherapy (•) or radiotherapy)

• • • •

| 2 days | 5 days | 2 days | 5 days | 2 days | 5 days | 2 days | 5 days | 2 days |

• • •

|2 days| 5 days |2 days| 5 days |2 days| 5 days |2 days| 5 days |2 days|

If chemotherapy regimens do not involve administration of hormones or drugs affecting the patient's hormonal status, treatment courses with the medicinal product ERBI SOL® ULTRApharm are combined with chemotherapy courses and administered 1–2 hours after chemotherapy drugs, preferably by intravenous infusion. In brain tumor chemotherapy, 5-day courses of temozolomide are combined with 5-day cycles of the medicinal product ERBI SOL® ULTRApharm.

During radiation therapy, 5-day irradiation cycles may be conducted together with 5-day administration cycles of the medicinal product ERBI SOL® ULTRApharm, separated by an interval of at least 3 hours.

Injections of the medicinal product ERBI SOL® ULTRApharm are preferably administered on an empty stomach, i.e., in the morning 1–2 hours before meals or in the evening 2–3 hours after meals. Tea, juices, water, and other beverages may be consumed at any time.

Children.

There is no experience of use in children (under 18 years of age).

Overdose.

Transient fatigue may occur, which does not require specific therapy.

Adverse Reactions.

ERBISOL® ULTRApharm is well tolerated by patients without manifestation of allergic reactions. However, in some cases during the first 2–5 days of treatment, the drug may cause an exacerbation of chronic inflammatory processes. This should not be regarded as a negative phenomenon, since in most cases it represents a stage of the therapeutic process. During clinical trials and throughout clinical use, no allergic reactions have been reported; however, the risk of their development cannot be completely excluded, namely: skin rashes, pruritus.

When administering an intensive therapy course with intravenous infusion of ERBISOL® ULTRApharm, an increase in arterial pressure and body temperature may occur during the first days of treatment, which should be reduced to normal levels. If the patient's condition is severe and body temperature continues to rise, the next 5-day cycle should be administered via intramuscular injection (2 times daily, 4 ml each time, in the morning and evening, daily for 5 days).

Shelf life: 5 years.

Do not use after the expiry date stated on the packaging.

Storage conditions: Store at 4–12 °C in a place inaccessible to children.

Opalescence may appear during storage.

Incompatibility.

Do not mix with other medicinal agents during administration. When diluting, use only the solutions specified in the section "Instructions for use and dosage".

Packaging: 10 ampoules of 1 ml or 2 ml.

Prescription category: Prescription only.

Manufacturers: LLC “ERBIS”,
PP “Laboratory ERBIS”.

E-mail: [email protected]

Website: www.erbisol.com.ua

Address: Ukraine, 02002, Kyiv, st. R. Okipnoi 10-B, office 92.

Tel: (044) 592-37-77