BRONXO-MUNAL

Active material: liofilizirovannыy lysate bacteria
When ATH: L03AX
CCF: The immunostimulatory preparation of bacterial origin
ICD-10 codes (testimony): H66, J00, J01, J02, J03, J04, J31, J32, J35.0, J37, J42
When CSF: 12.05.08.02
Manufacturer: LEK d.d. (Slovenia)

Pharmaceutical form, composition and packaging

Capsules hard gelatin, size №3, opaque, and the housing lid blue; contents of capsules – powder of light-beige.

1 caps.
liofilizirovannыy lysate bacteria: Streptococcus pneumoniae, Haemophilus influenzae, Klebsiella pneumoniae, Klebsiella ozaenae, Staphylococcus aureus, Streptococcus viridans, Streptococcus pyogenes, Moraxella catarrhalis7 mg

Excipients: propyl gallate (anhydrous), sodium glutamate (anhydrous), mannitol, magnesium stearate, pregelatinized starch, indigotin, Titanium dioxide, gelatin.

10 PC. – blisters (1) – packs cardboard.
10 PC. – blisters (3) – packs cardboard.

Bronxo-munal® P

Capsules hard gelatin, size №3, opaque, with a white body and a blue cap; contents of capsules – powder of light-beige.

1 caps.
liofilizirovannыy lysate bacteria: Streptococcus pneumoniae, Haemophilus influenzae, Klebsiella pneumoniae, Klebsiella ozaenae, Staphylococcus aureus, Streptococcus viridans, Streptococcus pyogenes, Moraxella catarrhalis3.5 mg

Excipients: propyl gallate (anhydrous), sodium glutamate (anhydrous), mannitol, magnesium stearate, pregelatinized starch, indigotin, Titanium dioxide, gelatin.

10 PC. – blisters (1) – packs cardboard.
10 PC. – blisters (3) – packs cardboard.

 

Pharmacological action

Immunomodulatory drugs bacterial origin. Modulates the immune response, It stimulates cellular and humoral immunity.

It reduces the frequency and severity of infections, thus reducing the need for antibiotics.

 

Pharmacokinetics

Data on the pharmacokinetics Broncho-munal® not provided.

 

Testimony

- Respiratory infections (in combined therapy as an immunomodulatory agent) in children between the ages of 6 Months before 12 years (Capsule 3.5 mg);

- Respiratory infections (in combined therapy as an immunomodulatory agent) adults and children over the age of 12 years (Capsule 7 mg);

- For the prevention of recurrent infections of the upper and lower respiratory tract (chronic bronchitis, tonsillitis, pharyngitis, laringit, rhinitis, sinusitis, otitis).

 

Dosage regimen

Adults and children over 12 years administered Broncho-munal® dose 7 mg; children aged 6 Months before 12 years administered Broncho-munal® II at a dose 3.5 mg.

The drug is taken in the morning on an empty stomach 1 caps. / day. If the patient / child can not swallow the capsule, it is recommended to open, and the contents of the capsule to dissolve in a small amount of liquid (tea, milk or juice).

To prevention of infectious diseases of the respiratory tract drug use three 10-day courses with 20-day intervals between them.

IN acute period appoint 1 caps. / day until symptoms of the disease, but not less than 10 days. In the following 2 Months possible preventive use of the drug by 1 caps. during 10 days of the 20-day interval between courses.

 

Side effect

During the entire period of clinical application of the drug undesirable effects were registered rarely.

In the specific case: disorders of the digestive system (epigastric pain, nausea, vomiting, diarrhea), fever.

If side effects are expressed slightly, discontinuation of the drug is not required. When hypersensitivity reactions is recommended removal of the drug.

 

Contraindications

- Individual hypersensitivity to the drug.

 

Pregnancy and lactation

Use of the drug Broncho-moon® during pregnancy and lactation is possible only in case, when the intended benefits to the mother outweighs the potential risk to the fetus or infant.

 

Cautions

By the use of oral vaccines and taking Broncho-moon® should observe a 4-week interval.

Do not use the drug in acute intestinal diseases due to a possible decrease in efficacy.

Use in Pediatrics

The drug is not prescribed children under the age of 6 Months.

To avoid overdose Children from 6 Months before 12 years appoint only Broncho-moon® P (capsules, containing 3.5 mg of freeze-dried product).

Effects on ability to drive vehicles and management mechanisms

No special precautions.

 

Overdose

There was no any clinical symptoms of overdose. There are no reports of toxicity due to overdose.

 

Drug Interactions

The preparation may be administered simultaneously with other drugs, including antibiotics.

 

Conditions of supply of pharmacies

The drug is released under the prescription.

 

Conditions and terms

The drug should be stored out of reach of children at temperature from 15 ° to 25 ° C. Shelf life – 5 years.

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