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Instructions for use Anaferon children's drops

Compound:

Active substances: affinity purified antibodies to human interferon gamma – 0.006 g*.
* are administered as a mixture of three active aqueous dilutions of the substance, diluted 10012, 10030, 10050 times, respectively.

Excipients: maltitol - 0.06 g, glycerol - 0.03 g, potassium sorbate - 0.00165 g, anhydrous citric acid - 0.0002 g, purified water - up to 1 ml.

Description

Colorless or almost colorless transparent liquid.

Pharmacotherapeutic group

Antiviral and immunostimulating agent.

ATX code

L03AX

pharmachologic effect

Pharmacological action – immunomodulatory, antiviral.

Preclinical and clinical studies have proven the effectiveness of the drug against influenza viruses, herpes simplex viruses types 1 and 2 (labial herpes, genital herpes), other herpes viruses (varicella, infectious mononucleosis), and rotavirus.

The drug reduces the concentration of the virus in the affected tissues, affects the system of endogenous interferons and associated cytokines, induces the formation of endogenous “early” interferons (IFN-a/β) and gamma interferon (IFN-γ). Stimulates the humoral and cellular immune response. Increases the production of antibodies (including secretory IgA), activates the functions of T-effectors, T-helpers (Tx), normalizes their ratio. Increases the functional reserve of Tx and other cells involved in the immune response. It is an inducer of a mixed Tx1- and Th2-immune response: it increases the production of Tx1- (IFN-γ, IL-2) and Th2- (IL-4, -10) cytokines, restores (modulates) the Th1/Th2 balance. Increases the functional activity of phagocytes and natural killer cells (EK cells).

Pharmacokinetics

The sensitivity of modern physicochemical methods of analysis (gas-liquid chromatography, high-performance liquid chromatography, gas chromatography-mass spectrometry) does not allow assessing the content of the active substance of the drug Anaferon for children in biological fluids, organs and tissues, which makes it technically impossible to study pharmacokinetics.

Indications for use

Treatment of acute respiratory infections of the upper respiratory tract in children aged 1 month to 3 years inclusive.

Contraindications

Increased individual sensitivity to the components of the drug, children under 1 month of age. Hereditary fructose intolerance (due to the presence of maltitol).

Pregnancy and lactation

The safety of using Anaferon for children in pregnant women and during lactation has not been studied.

Directions for use and doses

10 drops per dose (drops are dosed into a spoon). On the first day of treatment: the first 2 hours, 10 drops every 30 minutes, then, for the remaining time, 3 more times at equal intervals. From 2 to 5 days: 10 drops 3 times a day.

The drug is taken without meals. On the first day of treatment, the first five doses of the drug should be taken between feedings or 15 minutes before feeding the child or taking fluids.

Side effect

When used according to the indicated indications and in the indicated dosages, no side effects were identified. Individual hypersensitivity reactions to the components of the drug are possible.

Overdose

No cases of overdose have been identified to date.

Interaction with other drugs

No cases of incompatibility with other drugs have been reported to date.

special instructions

The drug contains maltitol, and therefore is not recommended for use in patients with congenital fructose intolerance.

Impact on the ability to drive vehicles and machinery

There are no data on the effect on the ability to drive vehicles and operate machinery.

Release form

25 ml in colored glass bottles, sealed with tamper evident caps, with a dropper. Each bottle, along with instructions for medical use, is placed in a cardboard pack.

Storage conditions

At a temperature not higher than 25 °C. Keep out of the reach of children.

Best before date

3 years. Do not use after the expiration date.

Conditions for dispensing from pharmacies

Over the counter.

Evaluation of the effectiveness of anaferon for children in the nonspecific prevention of ARVI in primary schoolchildren

According to the Federal Service for Surveillance on Consumer Rights Protection and Human Welfare for 2005, about 16.5 million cases of acute respiratory viral diseases (ARVI) were registered among children under the age of 14 years, of which the share of cases of confirmed influenza amounted to 2.3% - more than 370 thousand [1].

Respiratory pathology is caused by about 300 types of pathogens. This is a large group of microorganisms, which includes not only viruses (influenza A and B viruses, adenovirus, parainfluenza virus, RS virus, rhino- and reoviruses, coronavirus and picornaviruses, etc.) - about 200 species, but also other pathogens : opportunistic infections, bacteria and fungi [2, 3].

Currently, there are three main ways to control ARVI and influenza: vaccination, chemotherapy and nonspecific prophylaxis [4]. Vaccination against influenza viruses, while providing a stable and long-lasting protective effect, unfortunately has a narrow focus. In addition, the constantly changing antigenic properties of the influenza virus, associated with its high variability, significantly complicate the implementation of complete vaccine prevention [5].

Chemotherapy involves the use of synthetic and natural substances that affect the reproduction of viruses. However, the rather narrow spectrum of action and the possibility of rapid development of viral resistance to drugs of this class limits their use [5].

In this regard, it is now quite natural to focus attention on nonspecific prevention of acute respiratory viral infections and influenza, associated primarily with an increase in the activity of natural anti-infective defense mechanisms.

Particular importance in programs for seasonal nonspecific prevention of influenza and ARVI is given to immunomodulatory agents and inducers of endogenous interferons [5]. Currently, an interesting drug is one of the representatives of this group - anaferon for children.

It contains affinity-purified antibodies to human γ-interferon (γ-INF): a mixture of homeopathic dilutions C12, C30 and C50. According to numerous literature data, anaferon for children has immunomodulatory and antiviral effects [6, 7, 8].

It is known that the production of interferons is an important component of a complete immune response to a viral infection and largely determines the nature of the course of the disease [9]. Anaferon has a versatile modulating effect on all parts of the immune system and interferon status [6, 8, 10]. Thus, anaferon induces and modulates the formation of endogenous “early” interferons α, β and, most importantly, γ-INF. Interferons suppress virus replication and prevent infection of other cells. Under the influence of anaferon, the functional activity of macrophages and NK cells (cytotoxic lymphocytes), which lyse already infected cells, also increases. All these processes underlie the relatively rapid antiviral effect of anaferon [6, 8, 10].

In addition, anaferon affects the production of endogenous cytokines, restores their activity and modulates functionally associated processes. Anaferon is an inducer of both cellular (through Th-1) and humoral (through Th-2) immune response: it increases the production of Th-1 cytokines (γ-IFN and interleukin (IL)-2) and Th-2 (IL-2). 4, IL-10). In addition, anaferon regulates the ratio of Th-1 and Th-2 activities and increases the production of antibodies (including secretory immunoglobulin A) [6].

Due to the use of special production technology, the active substance in the drug is contained in ultra-low doses. In this regard, anaferon is highly safe and can be widely used as a means of nonspecific prevention of influenza and ARVI during an epidemically dangerous period in organized children's groups [11]. Anaferon for children is indicated for healthy children for the prevention of acute respiratory viral infections and influenza, as well as for children belonging to the group of people who are often and long-term ill [12, 13, 14].

In January–February 2005, to study the effectiveness of children's Anaferon in the prevention of acute respiratory viral infections and influenza, we conducted a comprehensive study at a secondary school of a healthy child.

For prophylactic use, Anaferon for children was used during an epidemic period, 1 tablet per day for 40 days, sublingually. This scheme has proven itself on the positive side; it is simple and convenient to use in mass children’s groups [11, 12, 13, 14].

The study involved 200 children in 1st and 2nd grades aged 7 to 8 years. When forming the main and control groups, randomization (a simple method) was used, which ensured the homogeneity of the groups. The children who made up the main group (100 children) received anaferon for children for nonspecific prevention of ARVI. The control group (100 children) included children who did not receive nonspecific prevention of ARVI and influenza. As a result of randomization, children from both the main and control groups were present in each class. Analyzing the effectiveness of preventing influenza and ARVI with the drug Anaferon for children, it should be noted that during the epidemic, only 13% of children receiving this drug fell ill, while in the group of schoolchildren who did not receive non-specific means of preventing ARVI, 58% fell ill (Fig. 1).

Figure 1. Incidence rate of ARVI in children in organized children's groups

The security indicator was about 77.6%. Significance was assessed using two-sided Fisher's test (p < 0.001).

According to the objectives, the features of the course of ARVI, in particular, the severity of the disease, were separately analyzed.

Only 6 children from the main group had a severe course of ARVI, while in the control group 28 children suffered a severe acute respiratory disease. These differences are also significant according to the two-sided Fisher test (p < 0.001) (Fig. 2).

Figure 2. Proportion of children who suffered severe ARVI

When assessing pharmacoeconomic effectiveness, we used data from I. L. Shakhanina [15]. The cost of nonspecific prevention of ARVI with anaferon for children was 24,500 rubles. The cost of treating cases of ARVI is 74,200 rubles. Thus, the total costs in the main group amounted to 98,700 rubles. An assessment of the preventive effect showed that the use of Anaferon for children prevented 45 cases of ARVI, including 23 episodes of complications from ARVI. At the same time, the prevented economic damage amounted to 270,900 rubles. When comparing the costs of nonspecific prevention of ARVI with anaferon for children with the amount of prevented economic damage, it turned out that the economic benefit from the use of anaferon for children in junior high school per 100 children amounted to 172,200 rubles.

Based on the results of our study, the following conclusions can be drawn:

anaferon for children has shown high effectiveness as a means for nonspecific prevention of acute respiratory viral infections in children in secondary schools in relation to influenza and acute respiratory viral infections during an epidemically dangerous period, during the winter season of 2004-2005;
the absence of contraindications, as well as the absence of side effects, a convenient method (sublingual tablet) and a regimen of use (1 tablet once a day, daily for 40 days) allow the widespread use of Anaferon for children in mass children's groups;
anaferon for children can be successfully used for mass prevention of influenza and ARVI, as well as their complications in school groups during seasonal diseases of the respiratory tract;
The economic efficiency of using anaferon for children among primary school students, as studies have shown, is quite high.

Literature

Infectious disease incidence in the Russian Federation for January-December 2005. Reference information of the Federal Service for Surveillance in the Sphere of Protection of Consumer Rights and Human Welfare of the Federal State Health Institution, “Federal Center for Hygiene and Epidemiology.”
Evstropov A. N. Pathogens of acute respiratory viral infections in humans // Clinical antimicrobial chemotherapy. 2001. T. 3. No. 1-2. pp. 38-41.
Kolobukhina L.V. Viral respiratory tract infections//Russian Medical Journal. 2000. T. 8. No. 13-14. pp. 559-564.
Drinevsky V. P., Osidak L. V., Tsybalova L. M. Acute respiratory infections in children and adolescents: a practical guide / ed. O. I. Kiseleva. St. Petersburg: SpetsLit, 2003. P. 181.
Ershov F.I., Kasyanova N.V., Polonsky V.O. Is rational pharmacotherapy of influenza and other acute respiratory viral infections possible? // Consilium Medicum. 2003. T. 5. No. 6. P. 129-135.
Osidak L.V., Afanasyeva O.I., Drinevsky V.P. Anaferon for children. A new remedy in the treatment and prevention of influenza and acute respiratory infections in children: a method. manual for doctors. St. Petersburg, 2003. P. 25.
Chuvirov G. N., Markova T. P. Antiviral therapy in the treatment of influenza // Russian Medical Journal. 2004. T. 12. No. 21. P. 1216-1226.
Uchaikin V.F., Epshtein O.I., Sergeeva S.A., Orlova T.G., Kharlamova F.S. et al. Anaferon for children. Domestic immunocorrector with antiviral activity: a manual for pediatricians and infectious disease specialists / ed. V. F. Uchaikina. M., 2003. P. 35.
Ershov F.I. The interferon system in normal conditions and in pathology. M.: Medicine, 1996. P. 240.
Martyushev-Poklad A. V. Mechanisms of antiviral and immunomodulatory effects of ultra-low doses of antibodies to interferon gamma: dis. ...cand. honey. Sci. Tomsk, 2003. 119 p.
Timchenko V. N., Chernova T. M. Modern methods of influenza prevention // Terra Medica. 2005. No. 4. P. 14-18.
New opportunities for the prevention and treatment of acute respiratory viral infections in children: effectiveness and safety: Based on materials from the scientific and practical conference “Pharmacotherapy in Pediatrics” 2005 // Polyclinic. 2006. No. 1. P. 10-11.
Lytkina I. N., Volkova N. A. Experience in the use of some modern drugs during nonspecific prevention of ARVI in children's organized groups // Children's infections. 2004. No. 4. P. 49-54.
Kuprina N. P., Kokoreva S. P., Semenchenko L. V., Shishlova S. A., Ragozina V. N. Clinical and laboratory effectiveness of the use of “Anaferon for children” in the complex therapy of frequently ill children. // Childhood diseases. 2005. No. 3. P.54-58.
Shakhanina I. L., Osipova L. A. Economic losses from infectious diseases in Russia: values and trends // Epidemiology and infectious diseases. 2005. No. 4. pp. 19-21.

T. I. Garashchenko, Doctor of Medical Sciences, Professor L. I. Ilyenko, Doctor of Medical Sciences, Professor M. V. Garashchenko Russian State Medical University, Moscow