Broncho-Vaxom® for children (Broncho-Vaxom® children)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceLysates of bacteria [Haemophilus influenzae + Streptococcus pneumoniae + Streptococcus viridans + Streptococcus pyogenes + Klebsiella pneumoniae + Klebsiella ozaenae + Staphylococcus aureus + Moraxella catarrhalis]Lysates of bacteria [Haemophilus influenzae + Streptococcus pneumoniae + Streptococcus viridans + Streptococcus pyogenes + Klebsiella pneumoniae + Klebsiella ozaenae + Staphylococcus aureus + Moraxella catarrhalis]
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  • Broncho-Vaksom® adult
    capsules inwards 
    OM Pharma SA     Switzerland
  • Broncho-Vaxom® for children
    capsules inwards 
    OM Pharma SA     Switzerland
    • Dosage form: & nbspcapsules
    Composition:

    One capsule contains:

    Active substance: lyophilizate of bacterial lysates (Haemophilus influenzae, Streptococcus pneumoniae, Klebsiella pneumoniae, Klebsiella ozaenae, Staphylococcus aureus, Streptococcus pyogenes, Streptococcus viridans, Moraxella catarrhalis) - 3,50 mg in the form of a standardized OM-85 lyophilizate * - 20.00 mg;

    Excipients: pregelatinized starch - 110,00 mg, magnesium stearate - 3,00 mg, mannitol - up to 200,00 mg.

    Capsule shell: indigocarmine - 0.01 mg, titanium dioxide - 1.00 mg, gelatin - up to 50.00 mg.

    Standardized OM-85 lyophilizate contains:

    Active substance: lyophilizate of bacterial lysates (Haemophilus influenzae, Streptococcus pneumoniae, Klebsiella pneumoniae, Klebsiella ozaenae, Staphylococcus aureus, Streptococcus pyogenes, Streptococcus viridans, Moraxella catarrhalis) - 3,50 mg.

    Excipients: anhydrous propyl gallate - 0.042 mg, anhydrous sodium glutamate - 1.515 mg, mannitol - up to 20.00 mg.

    Description:

    Hard gelatin capsule size of 3, the lid is blue opaque, the body is white opaque. The contents of the capsule are light beige powder.

    Pharmacotherapeutic group:Immunostimulating agent
    ATX: & nbsp

    L.03   Immunostimulators

    Pharmacodynamics:

    Characteristics of the preparation

    Lyophilisate of bacterial lysates Haemophilus influenzae, Streptococcus pneumoniae, Streptococcus viridans, Streptococcus pyogenes, Klebsiella pneumoniae, Klebsiella ozaenae, Staphylococcus aureus, Moraxella catarrhalis, used in the preparation Bronho-Vax® children's, is a bacterial extract containing lyophilized fractions of 21 strains of inactivated bacteria belonging to eight different species.

    The drug Bronho-Vaxom ® for children has an immunostimulating effect and enhances the immune defense of the body against respiratory tract infections.

    Pharmacodynamics

    Immunobiological action: Broncho-Vax® child causes an immune response mucosa the digestive tract. Especially the effect is manifested in Peyer's patches (PB) of the small intestine. Antigen presenting cells (APC) in the PB are activated bacterial lysate and subsequently stimulate cells responsible for the specific immunity.

    When using the drug Broncho-Vax® children's an increase in the number circulating B-lymphocytes. After stimulation of B-lymphocytes, an increase in the production of polyclonal antibodies is observed, especially IgG serum and IgA, secreted by the mucous membrane of the respiratory tract and salivary glands.

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

    Broncho-Vaxom®, a children's drug, has a powerful stimulating effect on most leukocytes, as evidenced by an increase in the number of myeloid and lymphoid cells and a selective increase in receptor expression on the surface.

    Together, these data are evidence that the drug Broncho-Vax® children trigger biological reactions that enhance the body's immune defense against respiratory tract infections. Clinically Broncho-Vaxom® children reduce the frequency of acute infections of the respiratory tract, shorten the duration of their course, reduce the likelihood of exacerbations of chronic bronchitis, and also increases resistance of the body to infections of the respiratory system. At the same time, the need to use other drugs, especially antibiotics, is reduced.

    Indications:

    The drug is used for children aged 6 months to 12 years for:

    - prevention of recurrent infection of the respiratory tract and exacerbations of chronic bronchitis;

    - complex treatment of acute respiratory tract infections.

    Contraindications:

    Hypersensitivity to the active component or to any of the auxiliary components of the preparation.

    Dosing and Administration:

    For the treatment of acute and exacerbation of chronic respiratory infections: one capsule of the preparation Bronho-Vaxom® for children daily on an empty stomach until the symptoms disappear, at least 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.

    The duration of treatment should be determined by the doctor based on the individual condition of the patient.

    For the prevention of exacerbations and maintenance therapy: one capsule of the preparation Bronho-Vaxom® for children daily in the morning on an empty stomach. The course of treatment includes three cycles, each consisting of a daily intake of one capsule for 10 days, an interval between cycles of 20 days.

    Children under 3 years of age or in case the child is difficult to swallow the capsule, it should be opened and mixed with the drink (water, fruit juice, milk, etc.).

    Side effects:

    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 side effects is upsetting 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:

    Often (≥1/10)

    Often (from 1/100 to 1/10)

    Infrequently (from 1/1 000 to 1/100)

    Rarely (from 1/10 000 to 1/1 000)

    Rarely (<1/10 000)

    Unknown (on the basis of available data, it is impossible to estimate)

    Disorders from the gastrointestinal tract:

    Often: diarrhea, abdominal pain

    Unknown: vomiting, nausea

    Disturbances from the nervous system:

    Unknown: headache.

    Disturbances from the respiratory system, chest organs of the mediastinum:

    Often: cough

    Disturbances from the skin and subcutaneous tissue:

    Often: rash

    Unknown: urticaria, angioedema

    General disorders and disorders at the site of administration:

    Unknown: fever, fatigue.

    Immune system disorders:

    Infrequently: hypersensitivity (rash erythematous, generalized rash, erythema, edema, eyelid edema, facial edema, peripheral edema, swelling, swelling of the face, itching, generalized itching, shortness of breath).

    Overdose:

    Data on cases of overdose are absent. The nature of the Bronho-Vaxom® child and the results of studying its toxicity on animals indicate that an overdose is unlikely.

    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.

    Special instructions:

    To prevent an overdose, children should not use the drug from capsules intended for adults (Broncho-Vaxom® adult capsules 7 mg).

    The components of the drug may cause a hypersensitivity reaction.

    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 allergic reactions.

    Bronho-Vaxom® for children should not be used in children under 6 months of age.

    Effect on the ability to drive transp. cf. and fur:

    Bronho-Vaxom® for children does not affect the ability to drive vehicles and mechanisms.

    Form release / dosage:Capsules, 3.5 mg.
    Packaging:

    10 capsules per blister, 1 or 3 blisters per pack of cardboard along with instructions for use.

    Storage conditions:

    Store at a temperature of 15 to 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    5 years.

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

    Terms of leave from pharmacies:Without recipe
    Registration number:П N011539 / 01
    Date of registration:23.12.2011 / 30.12.2015
    Expiration Date:Unlimited
    The owner of the registration certificate: OM Pharma SA OM Pharma SA Switzerland
    Manufacturer: & nbsp
    OM PHARMA, S.A. Switzerland
    Representation: & nbspSANDOZ SANDOZ Switzerland
    Information update date: & nbsp19.04.2017
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