Imunofan, 1 piece, 8.5 ml, 45 mcg/dose, metered nasal spray

Composition and release form

in blister packs 5 or 10 ampoules; in a cardboard pack 1 or 2 packages.

in blister packs 5 or 10 pcs.; in a cardboard pack 1 or 2 packages.

in a plastic bottle with a dosing device 8.5 ml; 1 bottle in a cardboard pack.

Pharmacodynamics

The drug has an immunoregulatory, detoxifying, hepatoprotective effect and causes inactivation of free radicals and peroxide compounds. Corrects the state of the immune system, restores the balance of the body's oxidative-antioxidative reactions and helps overcome multidrug resistance of tumor cells, mediated by proteins of the cell's transmembrane transport pump.

The effect of the drug begins to develop within 2–3 hours (fast phase) and lasts up to 4 months (medium and slow phases).

During the fast phase (duration - up to 2-3 days), the detoxification effect is manifested primarily - the body's antioxidant defense is enhanced due to stimulation of the production of ceruloplasmin, lactoferrin, and catalase activity; the drug normalizes lipid peroxidation, inhibits the breakdown of cell membrane phospholipids and the synthesis of arachidonic acid, with a subsequent reduction in blood cholesterol levels and the production of inflammatory mediators. In case of toxic and infectious liver damage, the drug prevents cytolysis, reduces the activity of transaminases and the level of bilirubin in the blood serum.

During the middle phase (begins after 2-3 days, duration - up to 7-10 days), the reactions of phagocytosis and death of intracellular bacteria and viruses intensify.

During the slow phase (begins to develop on 7–10 days, duration up to 4 months), the immunoregulatory effect of Imunofan® is manifested - restoration of impaired indicators of cellular and humoral immunity. During this period, normalization of the immunoregulatory index is observed, and an increase in the production of specific antibodies is noted. The effect of the drug on the production of specific antiviral and antibacterial antibodies is equivalent to the effect of therapeutic vaccines. Unlike the latter, the drug does not have a significant effect on the production of reagin antibodies of the IgE class and does not enhance the immediate hypersensitivity reaction; Imunofan® stimulates the formation of IgA in case of congenital deficiency.

Imunofan® effectively suppresses multidrug resistance of tumor cells and increases their sensitivity to the effects of chemotherapy drugs.

Imunofan spray nasal doser 45 µg/dose fl 40 doses

Release form

Spray for nasal use, dosed, transparent or slightly opalescent colorless or slightly yellowish liquid. A slight specific odor is allowed.

Package

In a plastic bottle with a dispensing device 8.5 ml; 1 bottle in a cardboard pack.

pharmachologic effect

The drug has an immunoregulatory, detoxifying, hepatoprotective effect and causes inactivation of free radicals and peroxide compounds. The pharmacological action is based on achieving three main effects: correction of the immune system, restoration of the balance of the body's oxidative-antioxidative reaction and inhibition of multidrug resistance mediated by proteins of the cell transmembrane transport pump.

The effect of the drug begins to develop within 2-3 hours (fast phase) and lasts up to 4 months (medium and slow phases).

During the fast phase (duration - up to 2-3 days), the detoxification effect is manifested primarily - the body's antioxidant defense is enhanced by stimulating the production of ceruloplasmin, lactoferrin, and catalase activity; the drug normalizes lipid peroxidation, inhibits the breakdown of cell membrane phospholipids and the synthesis of arachidonic acid, with a subsequent reduction in blood cholesterol and the production of inflammatory mediators.

In case of toxic and infectious liver damage, the drug prevents cytolysis, reduces the activity of transaminases (AST, ALT) and the content of bilirubin in the blood serum.

During the middle phase (begins after 2-3 days, duration - up to 7-10 days), the reactions of phagocytosis and death of intracellular bacteria and viruses intensify.

During the slow phase (begins to develop on days 7-10, duration up to 4 months), the immunoregulatory effect of Imunofan is manifested - restoration of impaired indicators of cellular and humoral immunity. During this period, normalization of the immunoregulatory index is observed, an increase in the production of specific antiviral and antibacterial antibodies is observed, equivalent to the effect of some therapeutic vaccines. Unlike the latter, the drug does not have a significant effect on the production of reagin antibodies of the IgE class and does not enhance the immediate hypersensitivity reaction; Imunofan stimulates the formation of IgA in case of congenital deficiency.

Imunofan effectively suppresses multidrug resistance of tumor cells and increases their sensitivity to the action of cytostatic drugs.

Indications

Prevention and treatment in adults and children over two years of age:

• Immunodeficiency and toxic conditions.
• Chronic inflammatory diseases of various etiologies.

Contraindications

• Hypersensitivity;
• Pregnancy complicated by Rh conflict;
• Children under 2 years of age.

Use during pregnancy and breastfeeding

Due to insufficient knowledge, it should be used with caution during pregnancy and lactation.

special instructions

As a result of activation of phagocytosis, a short-term exacerbation of foci of chronic inflammation, maintained due to the persistence of viral or bacterial antigens, is possible.

Compound

Directions for use and doses

Intranasally.

When using, the bottle should be held vertically, with the sprayer facing up.

1. Remove the protective cap from the sprayer.
2. Before first use, fill the dosing pump by pressing the wide rim of the spray nozzle 3-4 times.
3. Insert the sprayer into the nasal passage with the head in a vertical position.
4. Press the wide rim of the spray nozzle once until it stops.

1 dose of the drug contains 50 mcg of imunofan. The daily dose should not exceed 200 mcg.

• In the complex therapy of acute and chronic infectious and inflammatory diseases accompanied by symptoms of intoxication and immunodeficiency,
  1 dose (50 mcg) is prescribed in each nasal passage 2 times a day, daily for 10-15 days.

• For opportunistic infections (cytomegalovirus and herpetic infections, toxoplasmosis, chlamydia, pneumocystis, cryptosporidiosis)
  1 dose (50 mcg) in each nasal passage 2 times a day, daily, course of treatment is 10-15 days. If necessary, the course can be repeated after 2-4 weeks.

• For chronic viral hepatitis and chronic brucellosis
  : 1 dose (50 mcg) in each nasal passage 1 time per day, daily, course of treatment for 10-15 days, to prevent relapse, repeated courses should be taken after 4-6 months.

• In the treatment regimen for patients with HIV infection
  : 1 dose (50 mcg) in each nasal passage 1 time per day, daily, for 10-15 days. If necessary, the course can be repeated after 2-4 weeks.
• When treating cancer patients in a radical combination treatment regimen (chemo-radiation therapy and surgery)
  : 1 dose (50 mcg) in each nasal passage 1 time per day, daily, for 8-10 days before chemo-radiation therapy and surgery subsequent continuation of the course throughout the entire treatment period.

• In patients with an advanced tumor process (stages III-IV) of various localization, in terms of complex or symptomatic therapy
  : 1 dose (50 mcg) in each nasal passage 1 time per day, daily, for 8-10 days. If necessary and in the presence of severe symptoms of toxicosis, it is recommended to repeat the course.

Side effects

Possible: individual intolerance, allergic reactions.

Drug interactions

Increases the effectiveness of other types of drug therapy: the use of imunofan helps overcome resistance to glucocorticosteroid therapy.

The drug can be prescribed in combination with anti-inflammatory steroidal and non-steroidal anti-inflammatory drugs.

Storage conditions

The drug is stored in a place protected from light at a temperature of 2°C to 10°C, out of the reach of children. It is not recommended to use the drug after the expiration date indicated on the package.

Best before date

2 years.

Conditions for dispensing from pharmacies

Dispensed with a doctor's prescription

Indications of the drug Imunofan®

Solution for intramuscular and subcutaneous administration and rectal suppositories

For adults and children over 2 years of age (prevention and treatment):

immunodeficiency and toxic conditions;

chronic inflammatory diseases of various etiologies.

For adults - as an adjuvant for vaccination against bacterial and viral infections.

Dosed nasal spray:

For adults and children over 2 years of age (prevention and treatment):

immunodeficiency and toxic conditions;

acute and chronic infectious and inflammatory diseases.

Directions for use and doses

SC or IM, rectally, intranasally.

Injection:

courses, single and daily dose - 50 mcg.

Suppositories:

single (daily) dose - 100 mcg (1 supp.).

Nasal spray:

When using, the bottle should be held vertically, with the sprayer facing up. Remove the protective cap from the sprayer. Before first use, fill the dosing pump by pressing the wide rim of the spray nozzle 3-4 times. Insert the sprayer into the nasal passage with the head in a vertical position. Press the wide rim of the spray nozzle once until it stops. One dose of the drug contains 50 mcg of imunofan. The daily dose should not exceed 200 mcg.

When treating cancer patients in a radical combination treatment regimen (chemoradiation therapy and surgery):

— 1 time per day, daily, course of treatment — 8–10 injections (8–10 supp. or 1 dose in each nasal passage for 8–10 days) before chemoradiotherapy and surgery, followed by repetition of courses throughout the entire treatment period , with a break of 15–20 days.

In patients with an advanced tumor process (stages III–IV) of various localizations in the form of complex or symptomatic therapy:

- 1 time per day, daily, course of treatment - 8-10 injections (8-10 supp. or 1 dose in each nasal passage for 8-10 days), with a break of 15-20 days and repeating courses throughout period of subsequent treatment.

In children with malignant diseases of the hematopoietic and lymphoid systems:

- 1 time per day, daily, course of treatment - 10-20 injections (10-20 supp.). The drug is prescribed throughout the course of chemoradiotherapy and after its completion to prevent the development of toxicosis.

In the complex therapy of acute and chronic infectious and inflammatory diseases accompanied by symptoms of intoxication and immunodeficiency:

- 1 dose (50 mcg) in each nasal passage 2 times a day, daily for 10–15 days.

In complex therapy of children with papillomatosis of the larynx and oropharynx:

— 1 time per day, daily, course of treatment — 10 injections (10 supp.).

For opportunistic infections (CMV and herpes infections, toxoplasmosis, chlamydia, pneumocystis, cryptosporidiosis):

— 1 time a day, daily, course of treatment — 15–20 injections (15–20 supp.) or 1 dose in each nasal passage 2 times a day, daily, course of treatment — 10–15 days. If necessary, courses can be repeated after 2–4 weeks.

In complex therapy of HIV infection:

— 1 time per day, daily, course of treatment — 15–20 injections (15–20 supp. or 1 dose in each nasal passage for 10–15 days). If necessary, it is possible to conduct repeated courses after 2–4 weeks.

For chronic viral hepatitis and chronic brucellosis:

- 1 time per day, daily, course of treatment - 15-20 injections (15-20 sup. or 1 dose in each nasal passage for 10-15 days), to prevent relapses, repeated courses should be carried out after 2-3 months ( for nasal spray - after 4–6 months).

For diphtheria:

- 1 time per day, daily, course of treatment - 8-10 injections (8-10 supp.). For diphtheria bacteria carriage - 1 time every 3 days. The course of treatment is 3–5 injections (3–5 supp.).

In the treatment of III-IV degree burns with symptoms of toxemia, septicotoxemia, in surgical patients with septic endocarditis, long-term non-healing wounds of the extremities, purulent-septic complications:

- 1 time per day, daily, course of treatment - 7-10 injections (7-10 supp.), if necessary, the course of treatment should be continued up to 20 injections (20 supp.).

For broncho-obstructive syndrome, cholecystopancreatitis, rheumatoid arthritis:

- 1 time every 3 days, course of treatment - 8-10 injections (8-10 supp.), if necessary, the course of treatment should be continued up to 20 injections (20 supp.) according to the same scheme.

When treating psoriasis:

— 1 time per day, daily, course of treatment — 15–20 injections (15–20 supp.).

Vaccinal prevention:

adults - once on the day of vaccination.

Clinical and immunological effectiveness of imunofan in opportunistic infections

A. V. Karaulov, Doctor of Medical Sciences, Professor

MMA im. I. M. Sechenova, Moscow

A new immunoregulatory peptide, imunofan, is a synthetic derivative of the hormone thymopoietin (arginyl-a-aspartyl-lysyl-valyl-tyrosyl-arginine). In a short time, it was studied in detail and introduced into clinical practice as a means of pathogenetic therapy. The success of Imunofan is largely determined by its origin (a third-generation drug based on synthetic immune hormones), a detailed study of the mechanism of action and a clear rationale for clinical use [1, 2].

In our clinic, the mechanisms of action of the drug and its clinical effectiveness in respiratory diseases have been studied for a decade. In particular, the clinical effectiveness of imunofan in chronic bronchitis was successfully demonstrated [3]. In continuation of these works, Professor N.A. Didkovsky was the first to identify the interferon-inducing property of immunofan, which served as another basis for its use in opportunistic infections. We used Imunofan in the treatment of 28 patients with chronic respiratory infection (chronic pharyngotracheitis, chronic bronchitis of chlamydial bacterial etiology) with severe dysfunction in all parts of the immune system, including inhibition of the induced production of interferon a and g (INF-a and -g) . The drug was prescribed 1 ml of 0.005% solution intramuscularly every two days, 10 injections per course of treatment. The drug was well tolerated. In a number of patients, after three to five injections, a moderate exacerbation of the inflammatory process was noted, which, as a rule, stopped on its own. The clinical effect of the drug was expressed in the disappearance of purulent sputum and other symptoms of respiratory infections, as well as in an improvement in general well-being and a noticeable increase in performance already at the beginning of treatment. It turned out that after a course of therapy with Imunofan, in the majority of patients (70%), the virus-induced production of IFN-a (previously reduced) increased by 2-6 times and the mitogen-stimulated production of IFN-g by 2-4 times, including in response to FGA. The effect of the therapy persisted for a long time and was more pronounced in particularly severe cases of the disease, when basic therapy was unsuccessful or immunotherapy that preceded our treatment was ineffective. The drug was easily tolerated, its use was accompanied by pronounced positive changes according to immunological examination tests in patients with initially altered immunity parameters.

According to other clinical observations that we carried out during the outpatient treatment of patients, Imunofan has established itself as a drug that also has anti-inflammatory activity, which was reflected in a more rapid normalization of the symptoms of respiratory opportunistic infections. A peculiarity of its use at this stage of treatment was the need for repeated courses of therapy over three months of observation. At the same time, courses of therapy were often prescribed in the absence of changes in the immune status, but in the presence of clinical manifestations of infection. Imunofan combined well with therapy used to treat concomitant diseases (coronary heart disease, gastrointestinal diseases, obstructive pulmonary diseases). Moreover, in a number of cases, synergism in the action of drugs was observed (when combined with anti-inflammatory drugs, cholesterol-lowering drugs, etc.).

An assessment of the condition of patients with opportunistic infections, such as cytomegalovirus (CMV) infection, toxoplasmosis, chlamydia, pneumocytosis, herpes infection, cryptosporidiosis, listeriosis, occurring against the background of an immunodeficiency state, and the use of imunofan for them was carried out at the Omsk Medical Academy. In these fairly extensive studies, 202 patients with various opportunistic infections were observed. The criterion for inclusion in the study was the presence of a typical clinical picture of the disease, confirmed by laboratory tests. Each patient underwent a full range of laboratory and instrumental studies.

The study group of patients (102 people) received treatment with imunofan against the background of basic therapy. The drug was used in the form of intramuscular injections once every two days - 5 injections, then once every four days - 5 injections. If necessary, the course of treatment could be increased to 15 doses.

Patients in the comparison group (100 people) received etiopathogenetic treatment (basic therapy), including an immunomodulatory complex (adaptogens, enterosorbents, UV rays and hemosorption).

Lymphadenopathy, arthralgomyalgia, low-grade fever, complaints of general weakness are characteristic of all opportunistic infections. Therefore, when assessing the therapeutic effectiveness of imunofan, its result was assessed according to the main syndromic manifestations of opportunistic infection.

Thus, the administration of the drug to patients stimulates the metabolic reactions of phagocytic cells, which is especially important for chronic viral infections (CMV, herp infection), accompanied by immunocomplex reactions. The use of Imunofan contributed to the restoration of the total number of lymphocytes. At the same time, the patients showed an improvement in the balance of lymphocyte subpopulations, which demonstrates an increase in IRI from 0.8±0.1 to 1.75±0.3 after completion of the course of treatment with imunofan.

Increased phagocytic activity and restoration of the balance of T-lymphocyte subpopulations in patients receiving imunofan are accompanied by positive dynamics on the part of the CEC, which, under certain conditions, are pathogenetic factors of inflammation, damage and the development of allergic exogenous alveolitis or glomerulonephritis.

The damaging effect is usually caused by soluble complexes formed in a small excess of antigen. In these cases, the damaging effect of the complex is realized mainly through the activation of complement, the release of lysosomal enzymes, the generation of superoxide radicals and the activation of the kallikrein-kinin system. Complexes formed in tissues are usually retained at the site of their formation, and in the case of acute or chronic infection they are found in the vessels of the glomerular apparatus of the kidneys, alveolar vessels, their basement membranes and surrounding tissue. The topography of CEC deposition is determined by the state of vascular permeability: where it is increased, the predominant deposition of CEC occurs. Thus, when CEC is deposited in the lungs, alveolitis occurs, and in severe cases, inflammation can take on an alternating character with tissue necrosis, hemorrhage, and partial or complete thrombosis is possible in the vessels.

Circulating immune complexes become pathogenic only under certain conditions, in the case of their prolonged circulation and disruption of the mechanisms by which the blood is cleared of complexes. The latter occurs when the phagocytic function of the RES is inhibited as a result of its overload.

Analysis of the data obtained on the effect of imunofan on the immune status of patients with opportunistic infections shows that the drug stimulates the phagocytic and T-cell immunity, enhances the elimination of CEC and does not have an allergenic effect.

The positive effect of imunofan on the immune response in patients was accompanied by its pronounced effect on the clinical course of the infectious process. The data obtained convincingly indicate that Imunofan enhances the antitoxic basic therapy of multiple organ pathologies and concomitant diseases, which is reflected in a reduction in the period of manifestations of certain clinical syndromes. With the use of Imunofan, patients noted the disappearance of weakness, normalization of sleep and mood, and improvement of appetite. There were no side effects from the administration of the drug to patients.

Literature.

1. Imunofan - a regulatory peptide in the treatment of infectious and non-infectious diseases / Ed. V. I. Pokrovsky. M., 1998. P. 119.
2. Karaulov A.V., Sokurenko S.I. Imunofan: immediate and long-term results of treatment of patients with chronic bronchitis // Medical Market. 2000. No. 34. pp. 21-24.
3. Karaulov A.V. // Attending physician. 2000. No. 4.