Respibron

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT RESPIBRON (Respibron)

Composition:

Active substance: lyophilized bacterial lysate;

One tablet contains 50 mg of lyophilized bacterial lysate, which includes 7 mg of bacterial lysate: Staphylococcus aureus 6×10⁹ CFU, Streptococcus pyogenes 6×10⁹ CFU, Streptococcus viridans 6×10⁹ CFU, Klebsiella pneumoniae 6×10⁹ CFU, Klebsiella ozaenae 6×10⁹ CFU, Haemophilus influenzae B 6×10⁹ CFU, Neisseria catarrhalis 6×10⁹ CFU, Streptococcus pneumoniae 6×10⁹ CFU (the latter bacterium contains 1×10⁹ CFU of each of the following types — TY1/EQ11, TY2/EQ22, TY3/EQ14, TY5/EQ15, TY8/EQ23, TY47/EQ24), and 43 mg of glycine used in the lyophilization process;

Excipients: colloidal hydrated silicon dioxide; microcrystalline cellulose; calcium hydrogen phosphate dihydrate; magnesium stearate; ammonium glycyrrhizinate; menthol powder flavor.

Pharmaceutical form. Sublingual tablets.

Main physicochemical properties: round, flat, whitish tablets with a score line on one side, containing brown specks, with a slight characteristic odor.

Pharmacotherapeutic group. Immunostimulants. ATC code L03AX.

Immunological and biological properties.

Respibron is an immunomodulator based on bacterial lysate obtained by mechanical lysis of microbial cells. This medicinal product enhances the body's resistance to infections by increasing the levels of serum and secretory antibodies, and by activating cellular and humoral factors of non-specific immunity. This reduces the frequency and severity of respiratory infections and prevents the need for antibiotic use.

Respibron has a dual mechanism of action:

• Activates non-specific resistance (rapid protection, within 2–4 weeks from the start of Respibron administration) through membrane antigens present in the formulation, by activating dendritic cells, neutrophils, macrophages, and NK cells; induces phagocytosis and cellular lysis by stimulating macrophage adhesion to bacteria;
• Activates specific immunity (long-term protection, lasting several years) by increasing the production of IL-2, specific serum IgA, IgG, IgM, and sIgA, and by activating effector CD4 and CD8 T-lymphocytes and B-lymphocytes.

Respibron is well absorbed through the oral mucosa.

Clinical characteristics.

Indications. Prevention of recurrent respiratory tract infections.

Contraindications. Hypersensitivity to the components of the medicinal product.

Autoimmune diseases.

Acute intestinal infections.

Interaction with other medicinal products and other forms of interaction. No interaction with other medicinal products, including antibiotics and mucolytic agents, has been observed.

The response may be suppressed in patients with congenital or acquired immunodeficiency, as well as in patients undergoing immunosuppressive or corticosteroid therapy.

Special precautions for use.

Use during pregnancy or breastfeeding. Although toxic effects of the drug were not observed in animal studies, the use of Respibron during pregnancy or breastfeeding is not recommended.

Due to its immunomodulatory effect, Respibron reduces the number and severity of recurrent respiratory tract infections in children who frequently and persistently suffer from such infections, as well as reduces the frequency, severity, and duration of exacerbations caused by recurrent respiratory infections.

If body temperature rises significantly at the beginning of treatment, administration of the medicinal product should be discontinued.

Respibron should not be used concomitantly with other immunostimulants.

In patients with a history of adverse reactions to bacterial lysates, asthma attacks may occur.

There are no clinical data demonstrating that the use of the drug can prevent pneumonia. Therefore, its use for pneumonia prevention is not recommended.

Ability to affect reaction speed when driving vehicles or operating machinery. The medicinal product does not affect the ability to drive vehicles or operate machinery.

Dosage and Administration.

For use in adults and children aged 2 years and older.

Prophylactic treatment: Respibron should be administered sublingually. One tablet should be dissolved under the tongue for 1–2 minutes, once daily for 10 days. After a 20-day break, repeat the 10-day course of treatment. The full prophylactic treatment course, during which maximum immunotherapeutic effect is achieved, lasts 3 months. During the full course, 30 tablets of Respibron should be taken. In other words, Respibron is administered in three 10-day courses over three months, with two 20-day breaks between them.

For younger children: it is recommended to first ensure the feasibility of using the drug in this form; crush the tablet, moisten it with boiled room-temperature water, and place the resulting paste-like mixture into the oral cavity.

Children. The drug is used in children aged 2 years and older.

Overdose.

There have been isolated cases of overdose—insomnia and abdominal pain were observed. Treatment is symptomatic.

Adverse Reactions.

Gastrointestinal disorders: vomiting, stomatitis, abdominal pain, nausea, and diarrhea.

Skin and subcutaneous tissue disorders: allergic reactions, including urticaria, pruritus, rash, and swelling.

Infections and infestations: rhinitis, bacterial tonsillitis, influenza.

General disorders and administration site conditions: fever, fatigue, and headache.

Respiratory, thoracic and mediastinal disorders: cough, throat pain.

Reporting of adverse reactions after drug registration is of great importance. It enables continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

Shelf life: 3 years.

Storage conditions: Store at a temperature not exceeding 25 °C in the original packaging and in a place inaccessible to children.

Packaging: 10 tablets per blister, 1 or 3 blisters per cardboard box.

Supply category:
Over-the-counter (without prescription).

Manufacturer:
Bruschettini s.r.l. / Bruschettini S.R.L.

Manufacturer's address and location of its operations:
Via Isonzo 6, 16147 Genova, Italy / Via Isonzo 6, 16147 Genova, Italy.

Marketing Authorization Holder:
Lallemand Pharma AG, Switzerland / Lallemand Pharma AG, Switzerland.

Address of the Marketing Authorization Holder and/or its representative:
Via Selva, 2, 6900 Massagno, Switzerland / Via Selva, 2, 6900 Massagno, Switzerland.

Manufactured for: «Mili Healthcare Limited», United Kingdom (+380 44 498-13-34).