Broncho-munal P - instructions for use, dose, side effects, contraindications

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Dosage form: & nbspcapsules

Composition:

1 capsule contains: active substances: standardized lyophilizate of bacterial lysates (OM-85) - 20.0 mg: lyophilized bacterial lysates - 3.50 mg: Haemophilus influenzae, Streptococcus pneumoniae, Streptococcus viridans, Streptococcus pyogenes, Klebsiella pneumoniae, Klebsiella ozaenae, Staphylococcus aureus, Moraxella catarrhalis;

Excipients: propyl gallate (anhydrous) - 0.042 mg; sodium glutamate (anhydrous) - 1,515 mg; Mannitol - up to 20,000 mg, magnesium stearate - 3,000 mg; pregelatinized starch - 110,000 mg, mannitol - up to 200,00 mg; capsule shell: indigotine E132 - 0.009 mg, titanium dioxide E171 - 0.98 mg, gelatin - up to 50 mg.

Description:Hard gelatin capsule size 3, the cover is blue opaque, the body is white opaque. Contents of capsules: light beige powder.

Pharmacotherapeutic group:Immunostimulating agent

ATX: & nbsp

Other immunostimulants

Pharmacodynamics:

The drug Bronho-munal® P 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, in particular, 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 mucous membrane 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 Broncho-munal® P, the protective properties of the body against bacteria and viruses are enhanced.

Clinically, Broncho-munal® P reduces the incidence of acute infections of the respiratory tract, shortens the course of their course, reduces the likelihood of exacerbations of chronic bronchitis, and increases the body's resistance to infections of the respiratory system. At the same time, the need to use other drugs, especially antibiotics, is reduced.

Indications:

Broncho-munal® P is used in children aged 6 months to 12 years:

- in the complex therapy of acute respiratory infections;

- for the prevention of recurrent infections of the respiratory tract and exacerbations of chronic bronchitis.

Contraindications:

- hypersensitivity to the components of the drug;

- pregnancy;

- the period of breastfeeding;

- Children's age is less than 6 months.

Pregnancy and lactation:

Studies in animals have not revealed a negative effect on the course of pregnancy. The safety and effectiveness of the drug during pregnancy and during breastfeeding has not been studied, therefore, the use of Bronho-munal® P during pregnancy and during breastfeeding is contraindicated.

Dosing and Administration:

The drug is taken 1 capsule per 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 is possible preventive use of the drug: courses for 10 days, the interval between courses is 20 days.

Side effects:

Broncho-munal® P is usually well tolerated.Most adverse reactions are classified in the general category with moderate to moderate severity. The most frequent manifestation of side effects is upsetting of the gastrointestinal tract, skin reactions and disorders of the respiratory system.

According to the World Health Organization (WHO), undesirable effects are classified 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 can not be determined on the basis of available data).

Disorders from the gastrointestinal tract often: diarrhea, abdominal pain; frequency is unknown: nausea, vomiting.

Disturbances from the respiratory system often: cough; infrequently: dyspnea.

Disturbances from the skin and subcutaneous tissues often: rash; frequency is unknown: urticaria, angioedema.

Immune system disorders infrequently: hypersensitivity reactions (rash erythematous, rash generalized, erythema, edema, eyelid edema, facial edema, peripheral edema, swelling, swelling of the face, itching, generalized itching).

Disturbances from the nervous system frequency is unknown: headache.

General disorders frequency is unknown: fever, fatigue.

Overdose:No reports of intoxication due to drug overdose. The nature of the Bronho-munal® P preparation and the results of studying its toxicity in animals indicate that an overdose is unlikely.

Interaction:

No interaction of the drug with other drugs was noted. The drug can be used concomitantly with other medicines, including antibiotics.

Special instructions:

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

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

Effect on the ability to drive transp. cf. and fur:

The drug does not affect the ability to concentrate and control vehicles, mechanisms.

Form release / dosage:

Capsules of 3.5 mg.

Packaging:

For 10 capsules in A1/PVC blister, 1 or 3 blisters in a cardboard box together with instructions for use.

Storage conditions:

At a temperature of 15 to 25 ° C.

The drug should be stored out of the reach of children.

Shelf life:

5 years.

Do not use the drug after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:П N011633 / 01

Date of registration:14.03.2008 / 12.10.2015

Expiration Date:Unlimited

The owner of the registration certificate:Sandoz d.Sandoz d. Slovenia

Manufacturer: & nbsp

LEK d.d. Slovenia

Representation: & nbspSANDOZ SANDOZ Switzerland

Information update date: & nbsp07.03.2017

Illustrated instructions

Instructions

Broncho-munal® P (Broncho-munal® P)