Broncho-Vaxom children's capsules 3.5 mg cor x10
Description of the drug BRONCHO-VAXOM CHILDREN Based on the officially approved instructions for use of the drug and prepared for the printed Vidal reference book 2016. Update date: 2015.07.03
Release form, packaging and composition Clinical-pharmacological. group Pharmacotherapeutic group Pharmacological action Pharmacokinetics Indications of the drug Dosage regimen Side effects Contraindications for use Special instructions Overdose Drug interactions Dispensing conditions from pharmacies Storage conditions Expiration date Contacts for requests
Marketing authorization holder: OM PHARMA, SA (Switzerland)
Contacts for inquiries: TAKEDA (Japan) ATX code: L03AX (Other immunostimulants)
Dosage form
Broncho-Vaxom® for children
Capsulereg. No.: P N011539/01 dated 12/23/11 - Indefinitely
Release form, packaging and composition of Broncho-Vaxom® for children
Hard gelatin capsules, size No. 3, blue opaque cap, white opaque body, capsule contents - light beige powder.
1 caps.
standardized lyophilisate of bacterial lysates:
Haemophilus influenzae, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus viridans, Klebsiella pneumoniae, Klebsiella ozaenae, Staphylococcus aureus, Moraxella catarrhalis 3.5 mg
Excipients: anhydrous propyl gallate (E310) - 0.042 mg, sodium glutamate - 1.515 mg, mannitol - up to 20 mg, pregelatinized starch - 110 mg, magnesium stearate - 3 mg, mannitol - up to 200 mg.
Composition of the capsule shell: indigo carmine (indigotine) dye (E132) - 0.01 mg, titanium dioxide (E171) - 1 mg, gelatin - up to 50 mg.
10 pieces. - blisters (1) - cardboard packs. 10 pieces. - blisters (3) - cardboard packs.
Clinical-pharmacological group: Immunostimulating drug of bacterial origin Pharmaco-therapeutic group: MIBP
pharmachologic effect
Immunostimulating drug of bacterial origin. Causes an immune response in the mucous membrane of the digestive tract. The effect is most pronounced in Peyer's patches (PB) of the small intestine. Antigen-presenting cells (APC) in the PB are activated by the drug and subsequently stimulate cells responsible for specific immunity.
When using the drug, an increase in the number of circulating B-lymphocytes is observed. Following stimulation of B lymphocytes, there is an increase in the production of polyclonal antibodies, especially serum IgG and IgA secreted from the respiratory mucosa and saliva. These antibodies are the first line of defense against a range of infectious agents (viruses and bacteria).
The drug has a powerful stimulating effect on most types of leukocytes, as evidenced by an increase in the number of myeloid and lymphoid cells, as well as a selective increase in the expression of receptors on their surface.
Taken together, these data confirm that the drug triggers biological reactions that enhance the body's immune defense against infection.
Clinically, Broncho-Vaxom® for children reduces the frequency of acute respiratory tract infections, shortens the duration of their course, reduces the likelihood of exacerbation of chronic bronchitis, and also increases the body's resistance to respiratory system infections. This reduces the need to use other medications, especially antibiotics.
Pharmacokinetics Data on the pharmacokinetics of the drug Broncho-Vaxom® for children are not provided.
Indications of the drug Broncho-Vaxom® for children
Children aged 6 months to 12 years:
prevention of recurrent respiratory tract infections and exacerbations of chronic bronchitis, treatment of acute respiratory tract infections (as part of complex therapy). ICD-10 codes
Dosage regimen
Broncho-Vaxom® for children is prescribed to children aged 6 months to 12 years.
For the treatment of acute and exacerbation of chronic respiratory infections: 1 capsule of Broncho-Vaxom® for children daily in the morning on an empty stomach until symptoms disappear, but for at least 10 days. If antibiotic therapy is necessary, Broncho-Vaxom® for 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 patient’s health condition.
For the prevention of exacerbations and maintenance therapy: 1 capsule of Broncho-Vaxom® for children daily in the morning on an empty stomach. The course includes 3 cycles, each of which consists of taking 1 capsule daily for 10 days, the interval between cycles is 20 days.
For children under 3 years of age or if the child has difficulty swallowing the capsule, it should be opened and the contents mixed with a drink (water, fruit juice, milk).
Side effect
Broncho-Vaxom® for children is usually well tolerated. Most adverse reactions fall into the general category of moderate to moderately severe. The most common side effects of the drug are skin reactions, disorders of the digestive tract and respiratory system.
In each particular category, side effects are grouped by system-organ class and presented in descending order of frequency: very often (≥1/10), often (from 1/100 to 1/10), infrequently (from 1/1000 to 1/100 ), rare (1/10,000 to 1/1000), very rare (<.1/10,000), unknown (cannot be estimated based on available data).
From the digestive system: often - diarrhea, abdominal pain, unknown - vomiting, nausea.
From the nervous system: unknown - headache.
From the respiratory system: often - cough.
Dermatological reactions: often - rash.
Allergic reactions: uncommon - hypersensitivity reactions (erythematous rash, generalized rash, erythema, eyelid swelling, facial swelling, peripheral edema, facial swelling, itching, generalized itching, shortness of breath), unknown - urticaria, Quincke's edema.
Other: unknown - fever, fatigue.
Contraindications for use
hypersensitivity to the components of the drug.
Use in children
Broncho-Vaxom® for children should not be used in children under 6 months of age.
special instructions
Broncho-Vaxom® for children should not be used in children under 6 months of age.
To avoid overdose, you should not use the drug from capsules intended for adults (Broncho-Vaxom® adult capsules 7 mg).
Components of the drug may cause hypersensitivity reactions. In 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.
Impact on the ability to drive vehicles and operate machinery
Broncho-Vaxom® for children does not affect the ability to drive vehicles or operate machinery.
Overdose There are no data on cases of overdose. The nature of the drug Broncho-Vaxom® for children and the results of studying its toxicity indicate that an overdose is unlikely.
Drug interactions
Broncho-Vaxom® for children can be used simultaneously with other medications for the treatment of acute and chronic respiratory diseases.
The interaction of the drug Broncho-Vaxom® for children with other drugs has not yet been established.
Storage conditions for Broncho-Vaxom® for children
The drug should be stored out of the reach of children at a temperature of 15° to 25°C.
Shelf life of Broncho-Vaxom® for children Shelf life is 5 years.
Terms of sale
The drug is approved for use as a means of OTC.
Contacts for inquiries
TAKEDA (Japan)
Takeda Pharmaceuticals LLC
119048 Moscow, Usacheva st. 2, p. 1 Business, fl. 5 Tel. Fax E-mail:
Broncho-Vaxom for children
Description of the drug BRONCHO-VAXOM CHILDREN Based on the officially approved instructions for use of the drug and prepared for the printed Vidal reference book 2016. Update date: 2015.07.03
Release form, packaging and composition Clinical-pharmacological. group Pharmacotherapeutic group Pharmacological action Pharmacokinetics Indications of the drug Dosage regimen Side effects Contraindications for use Special instructions Overdose Drug interactions Dispensing conditions from pharmacies Storage conditions Expiration date Contacts for requests
Marketing authorization holder: OM PHARMA, SA (Switzerland)
Contacts for inquiries: TAKEDA (Japan) ATX code: L03AX (Other immunostimulants)
Dosage form
Broncho-Vaxom® for children
Capsulereg. No.: P N011539/01 dated 12/23/11 - Indefinitely
Release form, packaging and composition of Broncho-Vaxom® for children
Hard gelatin capsules, size No. 3, blue opaque cap, white opaque body, capsule contents - light beige powder.
1 caps.
standardized lyophilisate of bacterial lysates:
Haemophilus influenzae, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus viridans, Klebsiella pneumoniae, Klebsiella ozaenae, Staphylococcus aureus, Moraxella catarrhalis 3.5 mg
Excipients: anhydrous propyl gallate (E310) - 0.042 mg, sodium glutamate - 1.515 mg, mannitol - up to 20 mg, pregelatinized starch - 110 mg, magnesium stearate - 3 mg, mannitol - up to 200 mg.
Composition of the capsule shell: indigo carmine (indigotine) dye (E132) - 0.01 mg, titanium dioxide (E171) - 1 mg, gelatin - up to 50 mg.
10 pieces. - blisters (1) - cardboard packs. 10 pieces. - blisters (3) - cardboard packs.
Clinical-pharmacological group: Immunostimulating drug of bacterial origin Pharmaco-therapeutic group: MIBP
pharmachologic effect
Immunostimulating drug of bacterial origin. Causes an immune response in the mucous membrane of the digestive tract. The effect is most pronounced in Peyer's patches (PB) of the small intestine. Antigen-presenting cells (APC) in the PB are activated by the drug and subsequently stimulate cells responsible for specific immunity.
When using the drug, an increase in the number of circulating B-lymphocytes is observed. Following stimulation of B lymphocytes, there is an increase in the production of polyclonal antibodies, especially serum IgG and IgA secreted from the respiratory mucosa and saliva. These antibodies are the first line of defense against a range of infectious agents (viruses and bacteria).
The drug has a powerful stimulating effect on most types of leukocytes, as evidenced by an increase in the number of myeloid and lymphoid cells, as well as a selective increase in the expression of receptors on their surface.
Taken together, these data confirm that the drug triggers biological reactions that enhance the body's immune defense against infection.
Clinically, Broncho-Vaxom® for children reduces the frequency of acute respiratory tract infections, shortens the duration of their course, reduces the likelihood of exacerbation of chronic bronchitis, and also increases the body's resistance to respiratory system infections. This reduces the need to use other medications, especially antibiotics.
Pharmacokinetics Data on the pharmacokinetics of the drug Broncho-Vaxom® for children are not provided.
Indications of the drug Broncho-Vaxom® for children
Children aged 6 months to 12 years:
prevention of recurrent respiratory tract infections and exacerbations of chronic bronchitis, treatment of acute respiratory tract infections (as part of complex therapy). ICD-10 codes
Dosage regimen
Broncho-Vaxom® for children is prescribed to children aged 6 months to 12 years.
For the treatment of acute and exacerbation of chronic respiratory infections: 1 capsule of Broncho-Vaxom® for children daily in the morning on an empty stomach until symptoms disappear, but for at least 10 days. If antibiotic therapy is necessary, Broncho-Vaxom® for 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 patient’s health condition.
For the prevention of exacerbations and maintenance therapy: 1 capsule of Broncho-Vaxom® for children daily in the morning on an empty stomach. The course includes 3 cycles, each of which consists of taking 1 capsule daily for 10 days, the interval between cycles is 20 days.
For children under 3 years of age or if the child has difficulty swallowing the capsule, it should be opened and the contents mixed with a drink (water, fruit juice, milk).
Side effect
Broncho-Vaxom® for children is usually well tolerated. Most adverse reactions fall into the general category of moderate to moderately severe. The most common side effects of the drug are skin reactions, disorders of the digestive tract and respiratory system.
In each particular category, side effects are grouped by system-organ class and presented in descending order of frequency: very often (≥1/10), often (from 1/100 to 1/10), infrequently (from 1/1000 to 1/100 ), rare (1/10,000 to 1/1000), very rare (<.1/10,000), unknown (cannot be estimated based on available data).
From the digestive system: often - diarrhea, abdominal pain, unknown - vomiting, nausea.
From the nervous system: unknown - headache.
From the respiratory system: often - cough.
Dermatological reactions: often - rash.
Allergic reactions: uncommon - hypersensitivity reactions (erythematous rash, generalized rash, erythema, eyelid swelling, facial swelling, peripheral edema, facial swelling, itching, generalized itching, shortness of breath), unknown - urticaria, Quincke's edema.
Other: unknown - fever, fatigue.
Contraindications for use
hypersensitivity to the components of the drug.
Use in children
Broncho-Vaxom® for children should not be used in children under 6 months of age.
special instructions
Broncho-Vaxom® for children should not be used in children under 6 months of age.
To avoid overdose, you should not use the drug from capsules intended for adults (Broncho-Vaxom® adult capsules 7 mg).
Components of the drug may cause hypersensitivity reactions. In 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.
Impact on the ability to drive vehicles and operate machinery
Broncho-Vaxom® for children does not affect the ability to drive vehicles or operate machinery.
Overdose There are no data on cases of overdose. The nature of the drug Broncho-Vaxom® for children and the results of studying its toxicity indicate that an overdose is unlikely.
Drug interactions
Broncho-Vaxom® for children can be used simultaneously with other medications for the treatment of acute and chronic respiratory diseases.
The interaction of the drug Broncho-Vaxom® for children with other drugs has not yet been established.
Storage conditions for Broncho-Vaxom® for children
The drug should be stored out of the reach of children at a temperature of 15° to 25°C.
Shelf life of Broncho-Vaxom® for children Shelf life is 5 years.
Terms of sale
The drug is approved for use as a means of OTC.
Contacts for inquiries
TAKEDA (Japan)
Takeda Pharmaceuticals LLC
119048 Moscow, Usacheva st. 2, p. 1 Business, fl. 5 Tel. Fax E-mail:
