Broncho-Vaxom^® (Capsules) Instructions for Use

ATC Code

L03AX (Other immunostimulants)

Clinical-Pharmacological Group

Immunostimulating drug of bacterial origin

Pharmacotherapeutic Group

MIBP

Pharmacological Action

Immunostimulating drug of bacterial origin. It induces an immune response in the mucosa of the digestive tract. The effect is particularly pronounced in the Peyer’s patches (PP) of the small intestine. Antigen-presenting cells (APC) in the PP are activated by the drug and subsequently stimulate cells responsible for specific immunity.

Administration of the drug leads to an increase in the number of circulating B-lymphocytes. Following stimulation of B-lymphocytes, an increase in the production of polyclonal antibodies is observed, particularly serum IgG and IgA secreted by the respiratory mucosa and saliva. These antibodies serve as the first line of defense against a wide range of infectious agents (viruses and bacteria).

The drug exerts a powerful stimulatory effect on most types of leukocytes, as evidenced by an increase in the number of myeloid and lymphoid lineage cells, as well as a selective increase in receptor expression on their surface.

Collectively, these data confirm that the drug initiates biological responses that enhance the body’s immune defense against infection.

Clinically, Broncho-Vaxom^® adult reduces the frequency of acute respiratory tract infections, shortens their duration, decreases the likelihood of chronic bronchitis exacerbations, and increases the body’s resistance to respiratory system infections. This subsequently reduces the need for other medications, especially antibiotics.

Indications

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

Treatment of acute respiratory tract infections (as part of combination therapy).

ICD codes

Dosage Regimen

Administer orally. Use the dosage form appropriate for the patient’s age.

For prevention of recurrent respiratory tract infections and exacerbations of chronic bronchitis: Take one capsule daily on an empty stomach for 10 consecutive days per month. Continue this cycle for three consecutive months.

For treatment of acute respiratory tract infections as part of combination therapy: Take one capsule daily on an empty stomach until symptoms resolve, but for a minimum of 10 days.

For optimal absorption, take in the morning, at least 30 minutes before food or any other medication.

Swallow the capsule whole with a glass of water. Do not chew or crush.

If a dose is missed, take it as soon as remembered on the same day. Do not take a double dose to make up for a forgotten one.

Adverse Reactions

Gastrointestinal system Common – diarrhea, abdominal pain; Unknown – vomiting, nausea.

Nervous system Unknown – headache.

Respiratory system Common – cough.

Dermatological reactions Common – rash.

Allergic reactions Uncommon – hypersensitivity reactions (erythematous rash, generalized rash, erythema, eyelid edema, facial edema, peripheral edema, facial swelling, pruritus, generalized pruritus, dyspnea); Unknown – urticaria, angioedema.

Other Unknown – fever, fatigue.

Contraindications

Hypersensitivity to the components of the drug used, pregnancy, breastfeeding period.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and breastfeeding.

Pediatric Use

Used in children in the appropriate dosage form.

Special Precautions

In case of respiratory disorders or other symptoms of drug intolerance, treatment should be discontinued, as these symptoms are manifestations of an allergic reaction.

Drug Interactions

Can be used concomitantly with other drugs for the therapy of acute and chronic respiratory diseases.

Storage Conditions

Store at 15°C (59°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.