Nosological classification (ICD-10)
- H66 Suppurative and unspecified otitis media
- H70 Mastoiditis and related conditions
- J01 Acute sinusitis
- J02.9 Acute pharyngitis, unspecified
- J03.9 Acute tonsillitis, unspecified (angina agranulocytic)
- J04 Acute laryngitis and tracheitis
- J06 Acute upper respiratory tract infections of multiple and unspecified localization
- J18 Pneumonia without specifying the pathogen
- J22 Acute respiratory infection of the lower respiratory tract, unspecified
- J31.0 Chronic rhinitis
- J42 Chronic bronchitis, unspecified
- J45.8 Mixed asthma
Acute and chronic respiratory tract infections play an important role in pediatrics. Features of these diseases: 1) high incidence rate; 2) significant risk of complications; 3) the difficulty of differential diagnosis and identification of certain nosological forms, especially streptococcal pharyngitis, sinusitis and acute otitis media; 4) frequent and unjustified use of antibiotics; 5) significant contribution to health care costs and indirect social costs.
Acute respiratory tract infections (RTIs) remain one of the leading causes of child mortality. The proportion of deaths directly attributable to acute RDTIs accounts for 19% of all deaths in children under five years of age, mostly in low-income countries, namely Africa, Asia and Latin America. Although the etiological agents causing RTIs are not always well identified, viruses are considered the main cause. The most commonly identified pathogens are respiratory syncytial virus, adenovirus, parainfluenza and influenza viruses, as well as bacteria: Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, Klebsiella pneumoniae and S. pyogenes [1].
In high-income countries, RTI is one of the most common illnesses, resulting in 20% of medical consultations, 30% of days lost from work and 75% of antibiotic prescriptions. In the United States, the total cost of economic losses associated with FDW, excluding influenza, is approximately $40 billion per year [2]. More than 50% of outpatient consultations for children in the Russian Federation are related to respiratory tract infections [3].
Uncomplicated upper respiratory tract infections usually do not require antibiotics. However, some bacterial complications can occur against the background of acute respiratory viral infections (ARVI), such as acute otitis media, sinusitis and bronchitis. A study by R. Cohen [4] showed that the complication rate was 16.8% (10.9% - acute otitis media, 4% - laryngitis or bronchitis, 1.9% - pulmonary infections).
Excessive antibacterial therapy leads to an increase in bacterial resistance, limits the use of antibacterial agents, and increases the number of allergic reactions. Widespread use of antibiotics increases the risk of toxic reactions and the level of treatment costs. Thus, the rational use of antibiotics is still an important task for pediatricians [5].
The high level of IDPs in children of early and preschool age is explained by: 1) the high level of urbanization of the population (children in cities get sick more often than in rural areas); 2) exposure to harmful environmental factors; 3) non-compliance with hygiene rules in children's institutions; 4) exposure to respiratory pathogens within the family (siblings, caregivers); 5) defects of the immune system; 6) passive smoking.
Family predisposition serves as a risk factor for recurrent and severe forms of the disease. This genetic predisposition is associated with the anatomical, physiological and/or immunological characteristics of the child’s respiratory system [6]. Immune system defects are well known and may be associated with frequent RTIs. It was shown that 57% of children with recurrent RTIs (at least three episodes per year for at least 2 years) had a deficiency of one of the immunoglobulin (Ig) G subclasses, and 17% had an IgA deficiency [7]. Deficiencies of IgG subclasses are often detected in young children, but rarely in older children, which may be caused by transient immaturity of the immune system. Immune system defects, such as common variable immune deficiency and selective IgA deficiency, typically manifest as repeated episodes of respiratory infections caused by bacteria and viruses [8].
Prevention
The strategy for preventing IDPs consists of several activities: 1) informing parents about methods for preventing respiratory infections, the need to examine the child in the event of repeated episodes of respiratory infections and severe illness, about frequent cases of IDPs in the family, and the inadmissibility of frequent and uncontrolled use of antibacterial agents; 2) immunization in accordance with the National Vaccination Calendar; 3) physical education and sports, hardening procedures; 4) specific and nonspecific immunostimulation.
Vaccines represent the best opportunity to reduce morbidity and mortality caused by RTIs. The use of vaccines against influenza viruses, pneumococcus, and Haemophilus influenzae reduces the incidence of these infections. The use of antibiotics for the purpose of chemoprophylaxis should currently be strictly limited and relate to severe chronic diseases, for example, HIV infection, systemic immunodeficiency diseases, cystic fibrosis, common lung malformations and some others, because the occurrence of ARVI leads to an exacerbation of the underlying disease. The risk of the emergence of resistant forms of bacteria and the selection of sensitive strains remains a serious limitation to the widespread use of antibiotics. The effectiveness of surgical methods for the prevention of respiratory diseases (removal of tonsils, adenoids) is currently being actively discussed, and the frequency of these interventions is decreasing [9].
The correlation between recurrent UTIs and immune system defects mentioned above provides a rationale for nonspecific immunostimulatory therapy for patients with recurrent UTIs. For this purpose, bacterial immunostimulants are used. Over the past 3–4 decades, extensive clinical experience has been accumulated in the use of these drugs. It is known that bacterial ribosomes are highly immunogenic, while bacterial membrane proteoglycans act as excipients.
Ribomunil is a ribosomal immunomodulator of bacterial origin, which has been successfully used in clinical practice in recent years. The effectiveness of Ribomunil is due to its complex immunomodulatory effect. It contains ribosomal fractions of S. pneumoniae, S. pyogenes, H. influenzae, K. pneumoniae, as well as proteoglycans of the K. pneumoniae cell wall. An analysis of the effectiveness of including Ribomunil in a complex of rehabilitation measures for frequently ill children indicates the following: the rate of their recovery was significantly ahead of the similar indicators of the comparison groups [10, 11].
Ribomunil has been shown to be taken up by M cells in the intestine in contact with lymphocytes and dendritic cells. Specific lymphocytes can move to other places in the body, in particular to the respiratory system [12, 13]. Adhesion processes are important both for movement and for the performance of other functions by these cells. These processes involve several ligands and receptors expressed on phagocytes and endothelial cells. Ribomunil increased the expression of adhesion molecules not only in in vitro experiments, but also in placebo-controlled studies in humans [14].
In addition, the effect of Ribomunil on dendritic cells was noted. The drug induces membrane expression of CD83, CD86 and class II human leukocyte antigen molecules on dendritic cells, which is a marker of maturity for them. Additionally, increased production of interleukin-12 (IL-12) has been demonstrated [15], which may indicate that Ribomunyl-stimulated dendritic cells may also trigger a type I T helper cell response [16].
This immunostimulant has been shown to increase the production of various cytokines involved in the inflammatory response, such as tumor necrosis factor-α, monocyte chemotactic protein, IL-8 and -6.
Ribomunil also induces the production of interferon-γ by natural killer cells [17]. Finally, if Ribomunil triggers the TLR-2 pathway, it can stimulate the production of class 1 interferon (viral interferon) by antigen-presenting cells [18]. An increase in the titer of serum antibodies specific to four bacterial strains presented in Ribomunil was found, most of all Ig isotype A [19]. Moreover, IgA production in saliva increased sharply after two weeks of treatment, while the total amount of IgA remained unchanged. These specific IgA isotypes can completely inhibit bacterial adhesion to epithelial cells in vivo, and in a fairly physiological way [20]. Thus, as a result of a unique combination, this ribosomal vaccine has a dual mechanism of action, which allows it to be effectively used as a prophylaxis for bacterial and viral infections. All of the above data support the immunostimulating properties of Ribomunil and confirm its effectiveness in preventing recurrent infections or superinfections of the respiratory tract.
Clinical practice
A series of controlled clinical studies of children and adults has been published on the effectiveness of Ribomunil in respiratory diseases. These were studies that were conducted to an adequate level of compliance with Good Clinical Practice (GCP) standards and were sufficiently statistically representative. All these studies also assessed the effectiveness of prescribing Ribomunil according to official indications: for the prevention of IDPs in patients at risk of developing them at recommended doses. The use of ribosomal immunotherapy for 3 months led children with ENT infections to a statistically significant decrease in the frequency of respiratory infections compared to placebo (27 and 68%, respectively); the duration of episodes of IDP in patients receiving Ribomunil was lower than in the placebo group. The significance of the differences ranged from 0.05 to <0.001. As a result, fewer patients in the Ribomunil treatment groups required antibiotics than in the control groups, and there were fewer antibacterial courses per patient in the treatment groups than in the placebo group. After 6 months of treatment, these positive results were confirmed and in some cases improved, particularly with regard to the number of antibacterial courses and days of antibiotic use. When taking into account secondary criteria for the effectiveness of treatment, a significant difference was observed in such specific criteria as the percentage of children who required surgical interventions, such as tympanotomy or tonsillectomy (in the group receiving Ribomunil - 2%, in the placebo group - 21%, p = 0.02) , the average number of days missed from school. In studies conducted in children with mixed ENT/bronchopulmonary infections (318 children), similar results were obtained, with a significant reduction in the mean number of infections in patients receiving ribosomal immunotherapy compared with placebo. There was also a significant reduction in the average number of days with high fever in patients receiving ribosomal immunotherapy compared with placebo. Significantly less use of expectorants (p = 0.016) compared with placebo and an overall decrease in use of other drugs [21–23]. The use of Ribomunil for 1 to 6 months can successfully control the course of recurrent stenotic laryngotracheitis, promoting long-term (more than 3 years) remission of the disease [24]. Two double-blind studies were conducted among 475 patients with acute otitis media. Again, patients receiving ribosomal immunotherapy compared with placebo had fewer recurrent infections per patient (53% and 10% fewer in the two studies, respectively), and fewer antibiotic prescriptions (52 [p = 0.0018] and 26% fewer) [p = 0.05] respectively) and a significant reduction in the rate of adenoidectomy (p = 0.01 in one study) [22, 23]. Summarizing the data presented above, it can be noted: as a result of clinical studies, Ribomunil demonstrated effectiveness in the prevention of IDPs in children.
Many double-blind, placebo-controlled studies have been devoted to the use of Ribomunil in adults. The frequency of recurrent respiratory infections, as well as the number and duration of courses of antibiotics, were significantly reduced when the drug was prescribed to prevent recurrent respiratory infections [25, 26]. A multicenter study of Ribomunil in patients with chronic bronchitis showed that the drug prevents relapses in such patients [27]. Other double-blind studies reported significant reductions in the incidence of otitis media, sinusitis, and nasopharyngitis [28].
Ribomunil was also used to prevent IDPs in patients with bronchial asthma [29, 30]. I.K. Bogomolova et al. [31] used Ribomunil on 15 children with bronchial asthma aged 3 to 6 years. Clinical data, serum concentrations of Ig A, M, G, E, cytokines IL-1β, IL-4, tumor necrosis factor-α, interferon-γ, duration and frequency of ARVI episodes were assessed. It has been shown that under the influence of Ribomunil, immune defense factors are activated, the frequency and duration of acute respiratory viral infections are reduced, and the severity of clinical symptoms of diseases is reduced.
The use of Ribomunil helped reduce the frequency, severity and duration of acute respiratory viral infections, reduce asthma attacks, and normalize the ventilation capacity of the lungs. The influence of Ribomunil on immunoglobulin-mediated immunity was established, which consisted in the early stages of treatment in the correction of local immunity and acute-phase response, which led to a switch in the direction of immune reactions to inhibit allergic inflammation at later stages of therapy. Treatment with Ribomunil did not have a significant effect on thyroid hormonal status and glucocorticoid levels before and after the course of treatment with Ribomunil.
When studying the immunological parameters of children with asthma, an increase in the level of interferon-γ and a decrease in the level of IL-4 were noted. The clinical effect consisted of a reduction in the number of episodes of acute respiratory viral infections, asthma attacks, improvement in external respiratory function, and elimination of respiratory viruses from the nasopharyngeal epithelium [32, 33].
In his study, JA Hoffman [34] assessed the effectiveness of ribosomal immunotherapy in 338 children (age 4–17 years) with IDP and bronchial asthma. The main evaluation criterion was a clinical disease severity scale, which took into account the frequency of episodes of respiratory infections, the duration of episodes, fever, the need for antibacterial therapy, doctor visits, absences from school and work. Immunological parameters were taken into account as secondary efficacy criteria at the beginning of the study, after 4 and 7 months (end of the study). During the period of treatment with Ribomunil, the percentage of children protected from RTIs increased: the number of infectious episodes decreased (by 76%), the severity of clinical indicators (by 62%) and the need for antibiotics (by 71%) compared with the indicators before treatment. Immunological parameters corresponded to clinical improvements, in particular, there was a significant increase compared to the initial data in IgA at the 4th and 7th months, as well as IgG and IgM at the 7th (p < 0.05). The researchers concluded that these results support the clinical effectiveness of ribosomal immunostimulants for the prevention of RTI in children with bronchospastic syndrome.
Clinical experience with the use of Ribomunil in young children has been published. A study by JM Vautel [35] is devoted to the use of Ribomunil in children 1–4 years old. The purpose of this double-blind, placebo-controlled study was to determine the effectiveness and tolerability of Ribomunil in young children. Sixty-four children were included in the study and received treatment at the recommended dose. Significant decreases in all efficacy indicators were observed after 3 and 6 months in children receiving Ribomunil. After 6 months of treatment, the average number of infectious episodes was 3.39 in the Ribomunil group and 5.56 in the placebo group (39% decrease compared to placebo, p < 0.001), the average number of antibacterial courses was 1.32 in the Ribomunil group and 3.29 in the placebo group (60% reduction compared to placebo, p < 0.001). Other parameters, such as doctor visits (p < 0.01) and parental sick days (p-value not reported), were also better in children receiving ribosomal immunotherapy.
Safety and Tolerability
The clinical tolerability and safety of Ribomunil are considered quite good. Side effects associated with this drug are very rare in frequency and are similar in severity to placebo [23, 25]. In some studies, the percentage of children who had side effects was higher in the placebo groups (3.2%) than in the Ribomunil groups (1.6%). Side effects listed in the drug instructions include rare cases of mild ENT symptoms, fever, skin rashes and nausea. These data confirm that Ribomunil is a well-tolerated drug with side effects similar to placebo.
Conclusion
The use of Ribomunil has shown that its clinical effectiveness is associated with the stimulation of both specific and nonspecific immunity in children and adults, which helps prevent IDPs. A significant effect of Ribomunil on phagocytes and natural killer cells was noted. These cells appear to express receptors for bacterial components contained in Ribomunyl, the stimulation of which causes activation and/or maturation of these cell types. Such stimulation may be the underlying mechanism for most of the drug's biological effects in animals and humans [36]. In all double-blind, placebo-controlled studies, Ribomunil was effective in preventing recurrent ENT and bronchopulmonary infections. The drug reduced the number, severity and duration of infectious episodes, the number of antibacterial courses, concomitant medications (antitussives, expectorants, antipyretics, etc.) and the number of days parents missed school or work. It remains important to reduce the need for antibiotics during treatment with Ribomunil, which reduces the likelihood of developing antibacterial resistance.
Composition and release form
| Pills | 1 table |
| active components: bacterial ribosomes, titrated to 70% RNA | 0.75 mg |
| (including ribosomes Klebsiella pneumoniae - 3.5 shares, Streptococcus pneumoniae - 3.0 shares, Streptococcus pyogenes - 3.0 shares and Haemophilus influenzae - 0.5 shares) | |
| proteoglycans of the membrane part (including Klebsiella pneumoniae - 15 lobes) | 1.125 mg |
| other components: silicon - 1.5 mg; magnesium stearate - 6 mg; sorbitol - up to 294 mg |
4 pcs in blister; 1 blister in a box.
| Pills | 1 table |
| active components: bacterial ribosomes, titrated to 70% RNA | 0.25 mg |
| (including ribosomes Klebsiella pneumoniae - 3.5 shares, Streptococcus pneumoniae - 3.0 shares, Streptococcus pyogenes - 3.0 shares and Haemophilus influenzae - 0.5 shares) | |
| proteoglycans of the membrane part (including Klebsiella pneumoniae - 15 lobes) | 0.375 mg |
| other components: silicon - 0.5 mg; magnesium stearate - 2 mg; sorbitol - up to 98.4 mg |
12 pcs in blister; 1 blister in a box.
| Granules for the preparation of solution for oral administration | 1 pack |
| active components: bacterial ribosomes, titrated to 70% RNA | 0.75 mg |
| (including ribosomes Klebsiella pneumoniae - 3.5 shares, Streptococcus pneumoniae - 3.0 shares, Streptococcus pyogenes - 3.0 shares and Haemophilus influenzae - 0.5 shares) | |
| proteoglycans of the membrane part (including Klebsiella pneumoniae - 15 lobes) | 1.125 mg |
| other components: polyvidone - 10 mg; D-mannitol - up to 500 mg; silicon - 0.5 or 1.5 mg; magnesium stearate - 2 or 6 mg; sorbitol - up to 98.4 or 294 mg |
in sachets of 500 mg; There are 4 sachets in a box.
Pharmacodynamics
The ribosomal-proteoglycan complex is one of the most common causative agents of infections of the ENT organs and respiratory tract, and is a stimulator of specific and nonspecific immunity. The ribosomes included in its composition contain antigens identical to the surface antigens of bacteria, and when they enter the body they cause the formation of specific antibodies to these pathogens (vaccine effect). Membrane proteoglycans stimulate nonspecific immunity, which manifests itself in increased phagocytic activity of macrophages and polynuclear leukocytes and increased factors of nonspecific resistance. The drug stimulates the function of T- and B-lymphocytes, the production of serum and secretory immunoglobulins such as IgA, IL-1, as well as alpha and gamma interferon. This explains the preventive immunity of Ribomunil against respiratory viral infections. The use of Ribomunil in complex therapy can increase the effectiveness and shorten the duration of treatment, significantly reduce the need for antibiotics and bronchodilators, and increase the period of remission.
Ribomunil
Instructions for use:
RIBOMUNIL tablets
Registration number:
P N011369/01 dated 04/27/2010.
Trade name of the drug:
Ribomunyl.
International nonproprietary name:
does not have.
Dosage form.
Pills.
Compound.
1 tablet contains:
Active substances:
Ribosomal fractions: 0.75 mg (in terms of ribosomal RNA - 0.525 mg), Klebsiellapneumoniae - 3.5 shares, Streptococcuspneumoniae - 3.0 shares, Streptococcuspyogenes - 3.0 shares, Haemophilusinfluenzae - 0.5 shares, Membrane fraction: 1.125 mg, Klebsiellapneumonia - 15 shares.
0.525 mg) Klebsiellapneumoniae - 3.5 shares Streptococcuspneumoniae-3.0 shares Streptococcuspyogenes -3.0 shares
Haemophilusinfluenzae - 0.5 shares
Membrane fraction: 1.125 mg Klebsiellapneumonia - 15 shares
Excipients:
colloidal silicon dioxide -1.5 mg, magnesium stearate - 6.0 mg, sorbitol up to 294.0 mg.
Description.
Tablets are round, biconvex, white or almost white, odorless.
Pharmacotherapeutic group.
Immunostimulating agent of bacterial origin.
ATX Code:
L03AX.
Pharmacological properties.
Pharmacodynamics.
Ribomunil is a ribosomal-proteoglycan complex, which includes the most common pathogens of infections of the ENT organs and respiratory tract and is a stimulant of specific and nonspecific immunity. The ribosomes contained in the composition contain antigens identical to the surface antigens of bacteria, and when they enter the body they cause the formation of specific antibodies to these pathogens (vaccine effect). Membrane proteoglycans stimulate nonspecific immunity, which manifests itself in increased phagocytic activity of macrophages and polynuclear leukocytes and increased factors of nonspecific resistance. The drug stimulates the function of T and B lymphocytes, the production of serum and secretory immunoglobulins such as IgA, interleukin-1, as well as alpha and gamma interferon. This explains the preventive effect of Ribomunil against respiratory viral infections. The use of Ribomunil in complex therapy can increase the effectiveness and shorten the duration of treatment, significantly reduce the need for antibiotics and bronchodilators, and increase the period of remission.
Pharmacokinetics.
Ribomunil has good bioavailability. The macromolecules that make up Ribomunil do not undergo any special metabolism.
Indications for use.
Prevention and/or treatment of recurrent infections of the ENT organs (otitis, sinusitis, rhinitis, pharyngitis, laryngitis, acute tonsillitis) and respiratory tract (chronic bronchitis, tracheitis, pneumonia). Prevention of recurrent infections in patients at risk (frequently and for a long time ill, before the start of the autumn-winter season, especially in environmentally unfavorable regions, patients with chronic diseases of the ENT organs, chronic bronchitis, bronchial asthma).
Contraindications.
Hypersensitivity to the components of the drug, autoimmune diseases; acute intestinal infection; children under 6 years of age.
Carefully.
In patients with bronchial asthma, exacerbation of the disease is possible when taking immunostimulants containing bacterial components. If an asthmatic attack develops, the drug should be immediately discontinued and should not be resumed in the future. Use during pregnancy and breastfeeding.
No special studies have been conducted on the use of Ribomunil during pregnancy and breastfeeding. The use of Ribomunil during pregnancy and breastfeeding is possible only after assessing the expected benefit to the mother and the potential risk to the fetus and child.
Method of administration and dose.
Inside.
Adults and children over 6 years old - 1 time per day on an empty stomach. Single dose: 1 tablet. In the first month of treatment and/or for prophylactic purposes, Ribomunil is taken daily on the first 4 days of each week for 3 weeks; in the next 2-5 months: the first 4 days of each month. For young children, it is recommended to prescribe the drug in the form of granules. Side effect.
Rarely observed, characterized by:
Infectious and parasitic diseases:
rhinopharyngitis, sinusitis, laryngitis and bronchitis.
Immune system disorders:
hypersensitivity (urticaria, angioedema).
Disorders of the respiratory system, chest and mediastinal organs:
cough and exacerbation of bronchial asthma.
Digestive system disorders:
nausea, vomiting, diarrhea and abdominal pain, transient hypersalivation at the beginning of treatment.
Disorders of the skin and subcutaneous tissues:
eczema, erythema simplex and nodosum, vascular purpura.
General disorders and disorders at the injection site:
transient increase in body temperature (> 39 °C) at the beginning of treatment.
Overdose.
No significant adverse reactions were identified in case of drug overdose.
Interaction with other drugs and other types of interactions.
To date, no interaction with other drugs has been established. Ribomunil can be combined with medications such as: antibiotics, bronchodilators, anti-inflammatory drugs.
Special instructions.
A significant increase in body temperature (> 39° C) of unknown origin is possible, in which case the drug should be discontinued. This phenomenon should not be confused with a transient increase in body temperature, which is sometimes observed at the beginning of treatment and may be accompanied by minor and transient symptoms of infections from the ENT organs.
Release form.
Tablets 0.75 mg. 4 tablets in a PVC/aluminum foil blister. One blister along with instructions for use in a cardboard box.
Storage conditions.
At a temperature not exceeding 30° C. Keep out of the reach of children.
Best before date.
3 years. Do not use after expiration date.
, France.
RIBOMUNIL
granules for the preparation of solution for oral administration
Registration number:
P N011369/02 dated 04/27/2010.
Trade name of the drug:
Ribomunyl.
International nonproprietary name:
does not have.
Dosage form.
Granules for the preparation of a solution for oral administration.
Compound.
1 bag of granules contains:
Active substances:
Ribosomal fractions: 0.75 mg (in terms of ribosomal RNA - 0.525 mg), Klebsiellapneumoniae - 3.5 shares, Streptococcuspneumoniae - 3.0 shares, Streptococcuspyogenes - 3.0 shares, Haemophilusinfluenzae - 0.5 shares, Membrane fraction: 1.125 mg, Klebsiellapneumonia - 15 shares.
Excipients:
povidone - 10 mg, mannitol - 500 mg.
Description.
White granules, odorless.
Pharmacotherapeutic group.
Immunostimulating agent of bacterial origin.
ATX Code:
L03AX.
Pharmacological properties.
Pharmacodynamics.
Ribomunil is a ribosomal-proteoglycan complex, which includes the most common pathogens of infections of the ENT organs and respiratory tract and is a stimulant of specific and nonspecific immunity. The ribosomes contained in the composition contain antigens identical to the surface antigens of bacteria, and when they enter the body they cause the formation of specific antibodies to these pathogens (vaccine effect). Membrane proteoglycans stimulate nonspecific immunity, which manifests itself in increased phagocytic activity of macrophages and polynuclear leukocytes and increased factors of nonspecific resistance. The drug stimulates the function of T and B lymphocytes, the production of serum and secretory immunoglobulins such as IgA, interleukin-1, as well as alpha and gamma interferon. This explains the preventive effect of Ribomunil against respiratory viral infections. The use of Ribomunil in complex therapy can increase the effectiveness and shorten the duration of treatment, significantly reduce the need for antibiotics and bronchodilators, and increase the period of remission.
Pharmacokinetics.
Ribomunil has good bioavailability. The macromolecules that make up Ribomunil do not undergo any special metabolism.
Indications for use.
Prevention and/or treatment of recurrent infections of the ENT organs (otitis, sinusitis, rhinitis, pharyngitis, laryngitis, acute tonsillitis) and respiratory tract (chronic bronchitis, tracheitis, pneumonia). Prevention of recurrent infections in patients at risk (frequently and for a long time ill, before the start of the autumn-winter season, especially in environmentally unfavorable regions, patients with chronic diseases of the ENT organs, chronic bronchitis, bronchial asthma).
Contraindications.
Hypersensitivity to the components of the drug, autoimmune diseases; acute intestinal infection; children under 2 years of age.
Carefully.
In patients with bronchial asthma, exacerbation of the disease is possible when taking immunostimulants containing bacterial components. If an asthmatic attack develops, the drug should be immediately discontinued and should not be resumed in the future.
Use during pregnancy and breastfeeding.
No special studies have been conducted on the use of Ribomunil during pregnancy and breastfeeding. The use of Ribomunil during pregnancy and breastfeeding is possible only after assessing the expected benefit to the mother and the potential risk to the fetus and child.
Method of administration and dose.
Inside.
Adults and children over 2 years old - 1 time per day on an empty stomach.
Single dose: 1 bag of granules (granules are pre-dissolved in boiled water at room temperature). In the first month of treatment and/or for prophylactic purposes, Ribomunil is taken daily on the first 4 days of each week for 3 weeks; in the next 2-5 months: the first 4 days of each month.
Side effect.
Rarely observed, characterized by:
Infectious and parasitic diseases:
rhinopharyngitis, sinusitis, laryngitis and bronchitis.
Immune system disorders:
hypersensitivity (urticaria, angioedema).
Disorders of the respiratory system, chest and mediastinal organs:
cough and exacerbation of bronchial asthma.
Digestive system disorders:
nausea, vomiting, diarrhea and abdominal pain, transient hypersalivation at the beginning of treatment.
Disorders of the skin and subcutaneous tissues:
eczema, erythema simplex and nodosum, vascular purpura.
General disorders and disorders at the injection site:
transient increase in body temperature (> 39 °C) at the beginning of treatment.
Overdose.
No significant adverse reactions were identified in case of drug overdose.
Interaction with other drugs and other types of interactions.
To date, no interaction with other drugs has been established. Ribomunil can be combined with medications such as: antibiotics, bronchodilators, anti-inflammatory drugs.
Special instructions.
A significant increase in body temperature (> 39° C) of unknown origin is possible, in which case the drug should be discontinued. This phenomenon should not be confused with a transient increase in body temperature, which is sometimes observed at the beginning of treatment and may be accompanied by minor and transient symptoms of infections from the ENT organs.
Release form.
Granules for the preparation of a solution for oral administration 0.75 mg. 500 mg per laminated paper/aluminium sachet
foil/polyethylene. 4 sachets along with instructions for use in a cardboard box.
Storage conditions.
At a temperature not exceeding 30° C. Keep out of the reach of children.
Best before date.
3 years. Do not use after expiration date.
, France.
Indications for the drug Ribomunil
prevention and/or treatment of recurrent infections of the ENT organs (otitis, sinusitis, rhinitis, pharyngitis, laryngitis, tonsillitis) and respiratory tract (chronic bronchitis, tracheitis, pneumonia, infection-related bronchial asthma) in patients older than 6 months;
prevention of recurrent infections in patients at risk (frequently and for a long time ill, before the start of the autumn-winter season, especially in environmentally unfavorable regions, in patients with chronic diseases of the ENT organs, chronic bronchitis, bronchial asthma, including in children from 6 months and elderly patients).
Ribomunil gran.d/prepared solution d/pr.vn.in pack.500mg in pack No.4
Name
Ribomunyl.
Main active ingredient
Mibp
Release form
granules
Compound
1 sachet contains: Ribosomal fractions 10 parts, including: Ribosomes of Klebsiella pneumoniae 3.5 parts Ribosomes of Streptococcus pneumoniae 3.0 parts Ribosomes of Streptococcus pyogenes (group A) 3.0 parts Ribosomes of Haemophilus influenzae 0.5 parts Membrane fractions of Klebsiella pneumoniae 15 parts Excipients Povidone Yumg D-mannitol qs 500,000 mg
Description
White powder.
Dosage
500mg
Indications for use
This medicine is made from bacterial fractions. It is indicated for the prevention and treatment of recurrent infections of the JIOP organs (otitis, rhinitis, sinusitis, pharyngitis, laryngitis, tonsillitis) and respiratory tract (chronic bronchitis, tracheitis, pneumonia, infection-related bronchial asthma).
Contraindications
This medicine SHOULD NOT BE USED in the following cases: - you have a hypersensitivity (allergy) to the medicine or to one of its components. - in patients suffering from autoimmune disorders. IF YOU ARE IN ANY DOUBT, YOU SHOULD ALWAYS SEEK THE ADVICE OF YOUR DOCTOR OR PHARMACIST BEFORE TAKING ANY MEDICATION.
Directions for use and doses
Take 1 sachet 1 time per day: on an empty stomach in the morning, before meals. Pour the contents of the sachet into a glass, add water and stir. 1st month: 4 days a week for 3 weeks. The next five months: 4 days per month. IN ALL CASES, STRICTLY FOLLOW YOUR DOCTOR'S DIRECTIONS.
Side effect
LIKE ANY OTHER MEDICATION, THIS MEDICATION MAY CAUSE MORE OR LESS STRONG SIDE EFFECTS IN SOME INDIVIDUALS. - Temperature may increase during treatment. In this case, you should contact your doctor as soon as possible. — Rare cases of exacerbations have been described in patients with bronchial asthma after taking a drug containing bacterial extracts to stimulate the immune system. In this case, do not repeat the medication. - In rare cases, nasopharyngitis, sinusitis, laryngitis, bronchitis, and isolated cough may occur. - Allergic skin reactions (such as redness, itching, hives and rash) have been described. — At the beginning of treatment, transient hypersalivation is occasionally possible. - Rarely, gastrointestinal disturbances such as nausea, vomiting, diarrhea and abdominal pain may occur. DO NOT HESITATE TO CONSULT YOUR DOCTOR OR PHARMACIST AND TELL THEM ABOUT ANY UNPLEASANT OR UNWANTED SIDE REACTIONS THAT ARE NOT LISTED IN THE INSERT.
Overdose
If you take more RIBOMUNIL than you should, contact your doctor or pharmacist.
Storage conditions
There are no special storage conditions. Keep out of the reach of children.
Buy Ribomunil gran.d/prepared solution d/pr.vn.v pak.500mg in pack No. 4 in the pharmacy
Price for Ribomunil gran.d/prepared solution d/pr.vn.in pack.500mg in pack No.4
Instructions for use for Ribomunil gran.d/prepared solution d/pr.vn.in pak.500mg in pack No. 4
Directions for use and doses
Orally (for adults and children over 6 months), 1 time per day, in the morning, on an empty stomach. A single dose (regardless of age) is 3 tablets. 0.25 mg (with 1/3 of a single dose) or 1 tablet. 0.75 mg (with 1 dose), or granules from 1 sachet, pre-dissolved in boiled water at room temperature. In the first month of treatment and/or for prophylactic purposes, Ribomunil is taken daily 4 days a week for 3 weeks, in the next 5 months - the first 4 days of each month. It is recommended to use granules for young children.
