Instruction for use: Broncho-Vaxom children

Dosage form: capsules

Active substance: Bacteriolysates [Haemophilus influenzae + Streptococcus pneumoniae + Streptococcus viridans + Streptococcus pyogenes + Klebsiella pneumoniae + Klebsiella ozaenae + Staphylococcus aureus + Moraxella catarrhalis]

ATX

L03A Immunostimulants

Pharmacological group:

Other immunomodulators

The nosological classification (ICD-10)

J06 Acute upper respiratory tract infections of multiple and unspecified locations: Frequent colds of viral diseases; Infections of ENT organs; Acute respiratory illness of influenza nature; Pain for colds; Acute catarrhal disease; Cold; Colds; Colds; Respiratory infection; Seasonal catarrhal disease; Seasonal colds; Pain in infectious and inflammatory diseases of the upper respiratory tract; Bacterial infections of the upper respiratory tract; Bacterial infections of the respiratory system; Viral respiratory disease; Viral respiratory tract infections; Inflammatory disease of the upper respiratory tract; Inflammatory diseases of the upper respiratory tract; Inflammatory diseases of the upper respiratory tract with difficult to separate sputum; Inflammatory respiratory disease; Secondary infections for colds; Difficult sputum separation in acute and chronic respiratory diseases; Upper respiratory tract infections; Infections of the upper respiratory tract; Respiratory tract infections; Respiratory and lung infections; Infectious-inflammatory diseases of the upper respiratory tract; Infectious-inflammatory diseases of the upper respiratory tract and ENT organs; Infectious-inflammatory diseases of the upper respiratory tract in adults and children; Infectious-inflammatory diseases of the upper respiratory tract; Infectious inflammation of the respiratory tract; Respiratory tract infection; Qatar upper respiratory tract; Catarrh of the upper respiratory tract; Catarrh of the upper respiratory tract; Catarrhal phenomena from the upper respiratory tract; Cough in diseases of the upper respiratory tract; Cough for colds; ARVI; ARI; ARI with phenomena of rhinitis; Acute respiratory infection; Acute infectious-inflammatory disease of the upper respiratory tract; Acute respiratory disease; Persecution in the throat or nose; Respiratory and viral infections; Respiratory diseases; Respiratory infections; Recurrent respiratory tract infections; Secondary infections with influenza; Influenza states; Feverish conditions for influenza

J22 Acute respiratory infection of lower respiratory tract, unspecified: Bacterial respiratory disease; Bacterial infections of the lower respiratory tract; Bacterial infections of the respiratory system; Viral respiratory disease; Viral respiratory tract infections; Inflammatory respiratory disease;; Difficult sputum separation in acute and chronic respiratory diseases; Respiratory tract infections; Respiratory and lung infections; Lower respiratory tract infections; Infections of the lower respiratory tract; Infectious inflammation of the respiratory tract; Infectious diseases of the respiratory tract; Infectious diseases of the lungs; Infectious diseases of the respiratory system; Respiratory tract infection; Cough for colds; Pulmonary infection; Acute respiratory tract infection; Acute respiratory viral infection; Acute inflammatory airway disease; Acute respiratory disease; Respiratory infection; Respiratory and viral infections; Respiratory syncytial viral infection in young children; Respiratory diseases; Respiratory infections

J42 Chronic bronchitis, unspecified: Recurrent bronchitis; Asthmatic bronchitis; Asthmatic bronchitis; Bronchitis chronic; Inflammatory respiratory disease; Disease of the bronchi; Qatar smoker; Cough with inflammatory diseases of the lungs and bronchi; Exacerbation of chronic bronchitis; Chronic bronchitis; Chronic Obstructive Pulmonary Diseases; Chronical bronchitis; Chronic bronchitis of smokers; Chronic spasmodic bronchitis; Allergic bronchitis; Bronchitis allergic

J98.8 Other specified respiratory disorders: Recurrent respiratory infections

Composition

Capsules gelatinous 1 caps.

active substance:

Standardized lyophilizate of bacterial lysates (Haemophilus influenzae, Streptococcus pneumoniae, Streptococcus viridans, Streptococcus pyogenes, Klebsiella pneumoniae, Klebsiella ozaenae, Staphylococcus aureus, Moraxella catarrhalis) 3.5 mg

(In the composition of lyophilizate OM-85 - 20 mg)

Auxiliary substances: anhydrous propyl gallate (E310) - 0.042 mg; Sodium glutamate - 1,515 mg; Mannitol - to obtain 20 mg; Pregelatinized starch - 110 mg; Magnesium stearate - 3 mg; Mannitol - to obtain 200 mg

Capsule shell: indigo carmine dye (indigotine) (E132) 0.01 mg; Titanium dioxide (E171) - 1 mg, gelatin - the required amount to 50 mg

Description of dosage form

Capsules gelatinous solid size ¹3, lid and body opaque blue, the body is white opaque, the contents are light beige powder.

Pharmachologic effect

Mode action - immunomodulating.

Pharmacodynamics

Immunostimulating drug of bacterial origin. Causes an immune response to the mucosa of the digestive tract. Especially the effect is manifested in the Peyer's patches (PB) of the small intestine. Antigen presenting cells (APCs) in PB are activated by the drug and subsequently stimulate cells responsible for specific immunity.

When using the drug, there is an increase in the number of circulating B-lymphocytes.

After stimulation of B-lymphocytes, an increase in the production of polyclonal antibodies, especially IgG serum and IgA, secreted by the mucosa of the respiratory tract and saliva is observed.

These antibodies are the first line of defense against a number of infectious agents (viruses and bacteria)

The drug has a powerful stimulating effect on most types of leukocytes, evidenced by an increase in the number of cells of the myeloid and lymphoid series, as well as a selective increase in the expression of receptors on their surface.

Together, these data serve as confirmation that the drug triggers biological reactions that enhance the body's immune defense against infection.

Clinically, Broncho-Vaxom ® child reduces the incidence of acute respiratory tract infections, shortens the duration of their course, reduces the likelihood of exacerbations of chronic bronchitis, and increases the resistance of the body to infections of the respiratory system. This reduces the need for other drugs, especially antibiotics.

Indications for the preparation Broncho-Vaxom children

The drug is used in children from 6 months to 12 years of age according to the following indications:

Prevention of recurrent infection of the respiratory tract and exacerbations of chronic bronchitis;

Complex treatment of acute respiratory tract infections.

Contraindications

Hypersensitivity to the components of the drug.

Side effects

Immunostimulating drug Bronho-Vaxom ® for children is usually well tolerated. Most adverse reactions are classified in the general category with moderate to moderate severity. The most frequent manifestation of the side effect of the drug is a disorder of the gastrointestinal tract, skin reactions, disorders of the respiratory system.

In each particular category, side effects are grouped according to the system-organ class and are presented in descending order of frequency: very often (≥1 / 10); Often (from ≥1 / 100 to <1/10); Infrequently (from ≥1 / 1000 to <1/100); Rarely (from ≥1 / 10000 to <1/1000); Very rarely (<1/10000); It is not known (based on available data, it is impossible to estimate).

From the gastrointestinal tract: often - diarrhea, abdominal pain; Unknown - vomiting, nausea.

From the side of the nervous system: unknown - headache.

From the respiratory system, chest and mediastinum: often - cough.

From the skin and subcutaneous tissue: often - a rash; Unknown - urticaria, angioedema.

General disorders and disorders at the injection site: unknown - fever, fatigue.

On the part of the immune system: infrequently - hypersensitivity (rash erythematous, generalized rash, erythema, edema of the eyelids, edema of the face, peripheral swelling, swelling of the face, itching, generalized itching, shortness of breath).

Interaction

The drug can be used concomitantly with other drugs used in the treatment of acute and chronic respiratory diseases. Interaction with other drugs has not been established to date.

Dosing and Administration

Inside.

Treatment: 1 caps. Of the preparation Bronho-Vaxom® for children daily in the morning on an empty stomach until the symptoms disappear, but not less than 10 days. If it is necessary to carry out antibiotic therapy Bronho-Vaxom®, children should be taken in combination with an antibiotic from the beginning of treatment.

Duration of treatment or the appointment of a repeat course of therapy should be determined by the doctor, based on the patient's health status.

Preventive maintenance of exacerbations and maintenance therapy: 1 caps. Bronho-Vaxom® is given every morning on an empty stomach. The course includes 3 cycles, each of which consists of a daily intake of 1 caps. Within 10 days, the interval between cycles is 20 days.

In case the capsule is difficult to swallow, it should be opened and mixed with the drink (including fruit juice, milk).

Overdose

Information on cases of overdose are absent. The nature of the Broncho-Vaxom® adult and the results of a study of its toxicity indicate that an overdose is unlikely.

Special instruction

The components of the drug may cause hypersensitivity reactions.

In the case of persistent gastrointestinal disorders, skin reactions, respiratory disorders or other symptoms of intolerance to the drug, treatment should be discontinued, because These symptoms are a manifestation of an allergic reaction.

Influence on the ability to drive vehicles and mechanisms. Broncho-Vaxom® adult does not affect the ability to drive vehicles and mechanisms.

Release form

Capsules, 3.5 mg. In the blister is 10 pcs. 1 or 3 bl. In a pack of cardboard.

Manufacturer

OM Pharma SA. 22 Rue du Bois du Lahn, 1217 Meirin, Switzerland.

Name and address of the legal entity, whose name was issued a registration certificate: OM Pharma SA. 22 Rue du Bois du Lahn, 1217 Meirin, Switzerland.

Claims of consumers should be sent to the address of OOO Takeda Pharmaceuticals

Conditions of supply of pharmacies

Without recipe.

Storage conditions of the drug Broncho-Vaxom children

At a temperature of 15-25 ° C.

Keep out of the reach of children.

Shelf life of the drug Broncho-Vaxom children

5 years. Do not use after the expiry date printed on the package.

Do not use after the expiry date printed on the package.