ATX code: L03AX.
Pharmacotherapeutic group: immunostimulant.
Nosological classification: ICD-10
Pharmacological properties
Pharmacodynamics
Broncho-Munal® has an immune stimulating effect by strengthening the immunity against bacteria and viruses, respiratory tract infections.
After taking the capsule the bacterial lysate accumulates in the peyer’s plaques of the gastrointestinal mucosa, in particular those located in the small intestine. Antigen-presenting cells in the peyer plaques are activated by the bacterial lysate and subsequently stimulate other cell types (B-lymphocytes) responsible for specific immunity.
This leads to an increase in circulating B-lymphocytes, which leads to increased production of polyclonal antibodies, especially serum IgG and IgA, secreted by the respiratory tract mucosa and salivary glands.
The drug also affects non-specific immunity by stimulating leukocytes, characterized by increase of myeloid and lymphoid cells number and selective increase of receptors expression on their surface.
Clinically Broncho-Munal® reduces the frequency of acute respiratory tract infections, reduces the duration of their course, reduces the likelihood of exacerbations of chronic bronchitis, and also increases the body’s resistance to infections of the respiratory system. It also reduces the need to use other medications, especially antibiotics.
Indications
Runny nose (rhinitis), Laryngitis, Sinusitis, Respiratory tract infections, Pharyngitis, Sore throat, Bronchitis, Otitis, Tonsillitis Broncho-Munal ® is used:
– in the treatment of acute respiratory tract infections;
– for the prevention of recurrent respiratory tract infections and exacerbations of chronic bronchitis.
Active ingredient
Bacterial lysates
Composition
1 capsule contains:
The active ingredient:
– Bacterial lysates in the form of standardized bacterial lyophilisate (OM-85) (OM-Pharma, Switzerland) – 7,000 mg:
– Haemophilus influenzae
– Streptococcus pneumoniae
– Streptococcus viridans
– Streptococcus pyogenes
– Klebsiella pneumoniae <
– Klebsiella ozaenae
– Staphylococcus aureus
– Moraxella catarrhalis
Auxiliary substances:
– propyl gallate (anhydrous)
– sodium glutamate (anhydrous)
– mannitol (in the active ingredient) <
– magnesium stearate
– pregelatinized starch
– mannitol
Capsule shell:
– indigotine E132
– titanium dioxide E171
– gelatin
How to take, the dosage
Adults and children over 12 years. The preparation is taken in the morning, on an empty stomach 30 minutes before eating.
– For prevention of recurrent respiratory tract infections and exacerbations of chronic bronchitis the preparation is used in three courses of 10 days, the interval between courses is 20 days.
– In combination therapy of acute respiratory tract infections the preparation is used until symptoms disappear, but not less than 10 days. In case of antibiotic therapy Broncho-Munal® should be taken in combination with antibiotics from the beginning of treatment. Next two months the drug may be used prophylactically: courses of 10 days, the interval between courses is 20 days.
If the capsule is difficult to swallow it should be opened, the contents mixed with a small amount of liquid (such as tea, milk or juice).
Interaction
The drug can be used simultaneously with other medications, including antibiotics.
Special Instructions
Hypersensitivity reactions to the drug may occur. In case of persistent gastrointestinal disorders, skin reactions, respiratory disorders or other symptoms of intolerance to the drug should be discontinued and consult a physician.
The drug has no effect on the ability to concentrate and driving vehicles, mechanisms.
Synopsis
Gelatin capsules, solid, opaque, blue in color, size № 3. Capsule contents: light beige powder.
Contraindications
– Children under 12 years of age (children from 6 months to 12 years are recommended to take the preparation Broncho-Munal® P, 3,5 mg capsules).
– Pregnancy;
– Breast-feeding period;
– Children under 12 years of age.
Side effects
Broncho-Munal® is usually well tolerated. Most adverse reactions are classified into the general category with moderate to moderate severity. The most common side effects are gastrointestinal disorders, skin reactions and respiratory disorders.
According to the World Health Organization (WHO) adverse effects are classified according to their frequency of development as follows:
– very frequently (≥ 1/10);
– frequently (≥ 1/100, < 1/10);
– infrequently (≥ 1/1000, < 1/100);
– rarely (≥ 1/10000, < 1/1000);
– very rarely (< 1/10000);
– frequency is unknown (frequency of the phenomena cannot be determined on the basis of available data).
Gastrointestinal tract disorders:
– often: diarrhea, abdominal pain;
– frequency unknown: nausea, vomiting.
Respiratory system disorders:
– often: cough;
– infrequently: shortness of breath.
Skin and subcutaneous tissue disorders:
– often: rash;
– frequency unknown: urticaria, angioedema.
Immune system disorders:
– infrequent: hypersensitivity reactions (erythematous rash, generalized rash, erythema, edema, eyelid edema, facial edema, peripheral edema, swelling, swollen face, itching, generalized itching).
Nervous system disorders:
– frequency unknown: headache.
General disorders:
– frequency unknown: fever, fatigue.
Overdose
There are no reports of intoxication due to drug overdose. The composition of Broncho-Munal® and the results of its toxicity studies in animals indicate that overdose is unlikely.
Similarities
IRS-19, Imudon, Ismigen, Broncho-munal P, For sore throat and SARS
Weight | 0.011 kg |
---|---|
Shelf life | 5 years. Do not use the drug after the expiration date. |
Conditions of storage | At temperature from 15 ◦С to 25 ◦С. Keep out of reach of children. |
Manufacturer | Lek d.d., Slovenia |
Medication form | capsules |
Brand | Lek d.d. |
Other forms…
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