Treatment of ACUTE, subacute recurrent or chronic infections of the upper and lower respiratory tract. The preparation also works prophylactically preventing recurrent infections
Composition(formula) of Bacterial lysate
In animals, increased resistance to experimental infections, stimulation of macrophages and B lymphocytes as well as an increase in immunoglobulins secreted by the respiratory mucosal cells have been reported. In humans, an increase in the rate of circulating T lymphocytes, in salivary IgA, in the non-specific response to polyclonal mitogens and in the mixed lymphocyte reaction have been observed.
Absorption: The active ingredient of OM-85 is a bacterial extract comprising lyophilised fractions of 21 inactivated bacterial strains belonging to eight different species: Haemophilus influenzae, Streptococcus pneumoniae, Klebsiella pneumoniae ssp. pneumoniae and ssp. ozaenae, Staphylococcus aureus, Streptococcus pyogenes and sanguinis, Moraxella (Branhamella) catarrhalis. Due to the nature of the product, a conventional pharmacokinetic study cannot be performed, mainly because of the multiplicity of components and the lack of a suitable analytical method. No experimental model is currently available.
Distribution, Metabolism, Elimination: No data available.
Orally. Treatment of acute conditions: 1 tablet daily before eating, dissolve under the tongue. Use until the symptoms disappear for at least 10 days. Long-term treatment: 1 tabl. daily, dissolve under the tongue. Apply for 10 consecutive days a month for a period of 3 months
Interactions with other drugs is not known.
Hypersensitivity to the components of the preparation
In clinical trials, no adverse effects associated with the use of the preparation have been demonstrated
Animal studies have shown no evidence of fetal toxicity. Despite this, the administration is not recommended during the first trimester of pregnancy, if pregnancy is suspected and during lactation
No cases of overdose were observed.
Store in its original package, out of sight and reach of children. Broncho-Vaxom has a shelf life of 5 years. Do not store above 30°C. Do not use this medicinal product after the expiry date which is stated on the container after 'EXP'.
Active substance: Combination of bacterial lysates corresponding to lyophilized bacterial lysates of: Haemophilus influenzae, Streptococcus pneumoniae, Klebsiella pneumoniae ssp., pneumoniae and ozaenae, Staphylococcus aureus, Streptococcus pyogenes and sanguinis, Moraxella (Branhamella) catarrhalis.
Excipients of the capsules: Anhydrous propyl gallate, Monosodium glutamate (corresponding to anhydrous sodium glutamate), Pregelatinised starch, Magnesium stearate, Mannitol, color: indigotin (E 132), titanium dioxide (E171).
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