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Instructions

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Instruction for use: Broncho-munal

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Dosage form: capsules

Active substance: Bacteriolysates [Haemophilus influenzae + Streptococcus pneumoniae + Streptococcus viridans + Streptococcus pyogenes + Klebsiella pneumoniae + Klebsiella ozaenae + Staphylococcus aureus + Moraxella catarrhalis]

ATX

L03A Immunostimulants

Pharmacological group:

Other immunomodulators

The nosological classification (ICD-10)

J06 Acute upper respiratory tract infections of multiple and unspecified locations: Frequent colds of viral diseases; Infections of ENT organs; Acute respiratory illness of influenza nature; Pain for colds; Acute catarrhal disease; Cold; Colds; Colds; Respiratory infection; Seasonal catarrhal disease; Seasonal colds; Pain in infectious and inflammatory diseases of the upper respiratory tract; Bacterial infections of the upper respiratory tract; Bacterial infections of the respiratory system; Viral respiratory disease; Viral respiratory tract infections; Inflammatory disease of the upper respiratory tract; Inflammatory diseases of the upper respiratory tract; Inflammatory diseases of the upper respiratory tract with difficult to separate sputum; Inflammatory respiratory disease; Secondary infections for colds; Difficult sputum separation in acute and chronic respiratory diseases; Upper respiratory tract infections; Infections of the upper respiratory tract; Respiratory tract infections; Respiratory and lung infections; Infectious-inflammatory diseases of the upper respiratory tract; Infectious-inflammatory diseases of the upper respiratory tract and ENT organs; Infectious-inflammatory diseases of the upper respiratory tract in adults and children; Infectious-inflammatory diseases of the upper respiratory tract; Infectious inflammation of the respiratory tract; Respiratory tract infection; Qatar upper respiratory tract; Catarrh of the upper respiratory tract; Catarrh of the upper respiratory tract; Catarrhal phenomena from the upper respiratory tract; Cough in diseases of the upper respiratory tract; Cough for colds; ARVI; ARI; ARI with phenomena of rhinitis; Acute respiratory infection; Acute infectious-inflammatory disease of the upper respiratory tract; Acute respiratory disease; Persecution in the throat or nose; Respiratory and viral infections; Respiratory diseases; Respiratory infections; Recurrent respiratory tract infections; Secondary infections with influenza; Influenza states; Feverish conditions for influenza

J22 Acute respiratory infection of lower respiratory tract, unspecified: Bacterial respiratory disease; Bacterial infections of the lower respiratory tract; Bacterial infections of the respiratory system; Viral respiratory disease; Viral respiratory tract infections; Inflammatory respiratory disease;; Difficult sputum separation in acute and chronic respiratory diseases; Respiratory tract infections; Respiratory and lung infections; Lower respiratory tract infections; Infections of the lower respiratory tract; Infectious inflammation of the respiratory tract; Infectious diseases of the respiratory tract; Infectious diseases of the lungs; Infectious diseases of the respiratory system; Respiratory tract infection; Cough for colds; Pulmonary infection; Acute respiratory tract infection; Acute respiratory viral infection; Acute inflammatory airway disease; Acute respiratory disease; Respiratory infection; Respiratory and viral infections; Respiratory syncytial viral infection in young children; Respiratory diseases; Respiratory infections

J42 Chronic bronchitis, unspecified: Recurrent bronchitis; Asthmatic bronchitis; Asthmatic bronchitis; Bronchitis chronic; Inflammatory respiratory disease; Disease of the bronchi; Qatar smoker; Cough with inflammatory diseases of the lungs and bronchi; Exacerbation of chronic bronchitis; Chronic bronchitis; Chronic Obstructive Pulmonary Diseases; Chronical bronchitis; Chronic bronchitis of smokers; Chronic spasmodic bronchitis; Allergic bronchitis; Bronchitis allergic

J98.8 Other specified respiratory disorders: Recurrent respiratory infections

Composition

Broncho-munal®

Capsules 1 caps.

Active substances:

Standardized lyophilizate of bacterial lysates (OM-85) 40 mg (including lyophilized lysates of bacteria Haemophilus influenzae, Streptococcus pneumoniae, Streptococcus viridans, Streptococcus pyogenes, Klebsiella pneumoniae, Klebsiella ozaenae, Staphylococcus aureus, Moraxella catarrhalis - 7 mg); Propyl gallate (anhydrous) - 0.084 mg; Sodium glutamate (anhydrous) - 3.03 mg; Mannitol - up to 40 mg

Auxiliary substances: magnesium stearate - 3 mg; Pregelatinized starch - 110 mg; Mannitol - up to 200 mg

Capsule shell: indigotine (E132) - 0.03 mg; Titanium dioxide (E171) - 0.98 mg; Gelatin - up to 50 mg

Broncho-munal® P

Capsules 1 caps.

Active substances:

A standardized lyophilizate of bacterial lysates (OM-85) 20 mg (including lyophilized lysates of bacteria Haemophilus influenzae, Streptococcus pneumoniae, Streptococcus viridans, Streptococcus pyogenes, Klebsiella pneumoniae, Klebsiella ozaenae, Staphylococcus aureus, Moraxella catarrhalis 3.5 mg) ; Sodium glutamate (anhydrous) - 1,515 mg; Propyl gallate (anhydrous) - 0.042 mg; Mannitol - up to 20 mg

Auxiliary substances: magnesium stearate - 3 mg; Pregelatinized starch - 110 mg; Mannitol - up to 200 mg

Capsule shell: indigotine (E132) 0.009 mg; Titanium dioxide (E171) - 0.98 mg; Gelatin - up to 50 mg

Description of dosage form

Broncho-munal®

Capsules, 7 mg. A light beige powder, placed in hard gelatin capsules of size # 3, the lid and the body are blue opaque.

Broncho-munal® P

Capsules, 3.5 mg. Light beige powder, placed in hard gelatin capsule size 3, the lid is blue opaque, the body is white opaque.

Pharmachologic effect

Mode action - immunomodulating.

Pharmacodynamics

The drug has an immunostimulating effect, enhancing immunity against respiratory tract infections.

After taking the capsule, the bacterial lysate accumulates in Peyer's patches of the gastrointestinal mucosa, particularly those located in the small intestine. Antigen presenting cells in Peyer's plaques are activated by bacterial lysate and subsequently stimulate other cell types (B-lymphocytes) responsible for specific immunity. This leads to an increase in the number of circulating B-lymphocytes, which leads to an increase in the production of polyclonal antibodies, especially IgG serum and IgA, secreted by the mucosa of the respiratory tract and salivary glands. Also, the drug stimulates most leukocytes, which is characterized by an increase in the number of cells of the myeloid and lymphoid series, as well as a selective increase in the expression of receptors on the surface.

In patients receiving the drug, the protective properties of the body against bacteria and viruses are enhanced.

Clinically, the drug reduces the incidence of acute infections of the respiratory tract, shortens the duration of their course, reduces the likelihood of exacerbations of chronic bronchitis, and increases the body's resistance to respiratory infections. This reduces the need for other drugs, especially antibiotics.

Indications for the preparation Broncho-munal

In the complex therapy of acute respiratory infections;

Prevention of recurrent infections of the respiratory tract and exacerbations of chronic bronchitis.

Contraindications

pregnancy;

The period of breastfeeding;

Children under 12 years of age (for Broncho-munal®, capsule 7 mg);

Children's age to 6 months (for Bronho-munal® P, capsule 3.5 mg).

Application in pregnancy and breastfeeding

Studies in animals have not revealed a negative effect on the course of pregnancy. Safety and effectiveness of use during pregnancy and during breastfeeding has not been studied, so the use of the drug during pregnancy and during breastfeeding is contraindicated.

Side effects

The drug is usually well tolerated. The majority of adverse reactions are classified in the general category with moderate or moderately severe degree of manifestation. The most frequent manifestation of side effects is gastrointestinal disorders, skin reactions and disorders of the respiratory system.

Undesirable effects are given in accordance with the WHO classification according to their frequency of development as follows: very often (≥1 / 10); Often (≥1 / 100, <1/10); Infrequently ≥1 / 1000, <1/100); Rarely (≥1 / 10000, <1/1000); Very rarely (<1/10000); Frequency is unknown (the frequency of occurrence of phenomena cannot be determined on the basis of available data).

From the gastrointestinal tract: often - diarrhea, abdominal pain; Frequency unknown - nausea, vomiting.

From the respiratory system: often - cough; Infrequently - shortness of breath.

From the skin and subcutaneous tissues: often - a rash; Frequency unknown - hives, angioedema.

From the side of the immune system: infrequently - hypersensitivity reactions (rash erythematous, generalized rash, erythema, edema, including eyelid, face, peripheral edema, swelling, including facial, pruritus, including generalized) .

From the side of the nervous system: the frequency is unknown - the headache.

General disorders: the frequency is unknown - fever, fatigue.

Interaction

There was no interaction of the drug with other drugs. The drug can be used concomitantly with other drugs, including antibiotics.

Dosing and Administration

Broncho-munal®

Inside, 1 caps. The day in the morning, on an empty stomach, 30 minutes before meals.

For the prevention of recurrent infections of the respiratory tract and exacerbations of chronic bronchitis, the drug is administered three courses of 10 days, the interval between courses is 20 days.

In the complex therapy of acute respiratory infections, the drug is used until the symptoms disappear, but not less than 10 days. When carrying out antibiotic therapy, Bronho-munal® should be taken in combination with antibiotics from the beginning of treatment. The next 2 months may be preventive use of the drug courses for 10 days, the interval between courses is 20 days.

In case the capsule is difficult to swallow, it needs to be opened, mix the contents with a small amount of liquid (for example tea, milk or juice).

Broncho-munal® P

Inside, 1 caps. The day in the morning, on an empty stomach, 30 minutes before meals.

Children under 3 years old or if the child is difficult to swallow the capsule, it should be opened, mix the contents with a small amount of liquid (tea, milk or juice).

For the prevention of recurrent infections of the respiratory tract and exacerbations of chronic bronchitis, the drug is used three courses for 10 days, the interval between courses is 20 days.

In the complex therapy of acute respiratory infections, the drug is used until the symptoms disappear, but not less than 10 days. When carrying out antibiotic therapy, Bronho-munal® P should be taken in combination with antibiotics from the beginning of treatment.

The next 2 months may be preventive use of the drug courses for 10 days, the interval between courses - 20 days.

Overdose

There are no reports of intoxication due to an overdose of the drug. The composition of the preparation and the results of studying its toxicity in animals indicate that an overdose is unlikely.

Special instruction

Possible manifestations of reactions of hypersensitivity to the drug. In the case of persistent gastrointestinal disorders, skin reactions, respiratory disorders or other symptoms of intolerance, it is necessary to cancel the drug and consult a doctor.

Influence on the ability to drive vehicles, work with mechanisms. The drug does not affect the ability to concentrate and control vehicles, mechanisms.

Broncho-munal® P

To avoid an overdose, children from 6 months to 12 years of age should not use Bronho-Munal®, caps. 7 mg, intended for adults.

Release form

Broncho-munal®, capsules, 7 mg. For 10 caps. In the blister pack. By 1 or 3 bl. In a cardboard box.

Broncho-munal® P, capsules, 3.5 mg. For 10 caps. In the blister pack. By 1 or 3 bl. In a cardboard box.

Manufacturer

Sandoz d.d., Verovshkova 57, 1000, Ljubljana, Slovenia.

Produced: Lek dd, Verovshkova 57, Ljubljana, Slovenia.

BRONCHO-MUNAL® is a trademark of OM PHARMA, Geneva, Switzerland.

Claims of consumers to send to ZAO Sandoz

A comment

RU1609525814

Conditions of supply of pharmacies

Without recipe.

Storage conditions of the drug Broncho-munal

At a temperature of 15-25 ° C.

Keep out of the reach of children.

Shelf life of the drug Broncho-munal

5 years.

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

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