Instructions for use Respibron sublingual tablets No. 30
Composition
1 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 the following types - TY1/EQ11, TY2/EQ22, TY3/EQ14, TY5/EQ15, TY8/EQ23, TY47/EQ24), and 43 mg of glycine for the lyophilization process;
excipients: colloidal silicon dioxide; microcrystalline cellulose; calcium hydrogen phosphate, dihydrate; magnesium stearate; ammonium glycerysinate; menthol powder essence.
Dosage form
Sublingual tablets.
Main physicochemical properties: round, flat, whitish tablets with a score on one side, with brown inclusions, with a slight characteristic odor.
Pharmacotherapeutic group
Immunostimulants. ATX code L03A X.
Pharmacological properties
Immunological and biological properties.
Respibron is an immunomodulator based on bacterial lysate obtained by mechanical lysis of microbial cells. This drug increases the body's resistance to infections by increasing the number of serum and secretory antibodies, activating cellular and humoral factors of nonspecific immunity. This reduces the frequency and severity of respiratory infections, prevents the need for antibiotics.
Respibron has a dual mechanism of action:
activates nonspecific resistance (rapid protection, within 2-4 weeks from the start of taking Respibron) due to membrane antigens included in the drug, by activating dendritic cells, neutrophils, macrophages and NK cells; induces phagocytosis and cell lysis by stimulating adhesion of macrophages to bacteria;
activates specific immunity (long-term protection, for several years) by increasing the level of IL-2 production, specific serum IgA, IgG, IgM and slgA, activation of effector CD4 and CD8 T-lymphocytes, activation of B-lymphocytes.
Respibron is well absorbed in the oral mucosa.
Indication
Prevention of recurrent respiratory tract infections.
Contraindication
Hypersensitivity to the components of the drug.
Autoimmune diseases.
Acute intestinal infections.
Interaction with other medicinal products and other types of interactions
No interactions with other drugs, including antibiotics and mucolytics, were observed.
In congenital or acquired immunodeficiency, the response may be suppressed in patients undergoing immunosuppressive or corticosteroid therapy.
Use during pregnancy or breastfeeding
Although no toxic effects of the drug were observed in animal studies, it is not recommended to use Respibron during pregnancy or breastfeeding.
Due to its immunomodulatory effect, Respibron reduces the number and intensity of cases of recurrent respiratory tract infections in children who are often and for a long time ill, and also reduces the frequency and severity of exacerbations caused by recurrent respiratory tract infections.
If the temperature rises significantly at the beginning of treatment, you should stop taking the medicine.
Respibron should not be used simultaneously with other immunostimulants.
Patients who have a negative experience with the use of bacterial lysates may experience asthma attacks.
There is no clinical trial data to demonstrate that the drug can prevent pneumonia. Therefore, its use for the prevention of pneumonia is not recommended.
Ability to influence reaction speed when driving vehicles or other mechanisms
The medicine does not affect the ability to drive a car or other mechanisms.
Method of administration and doses
For use in adults and children from 2 years of age.
Preventive treatment: Respibron is used sublingually. Dissolve 1 tablet under the tongue for 1-2 minutes once a day for 10 days. After a 20-day break, repeat the 10-day course of taking the drug. The full course of preventive treatment, in which the maximum immunotherapeutic effect is achieved, is 3 months. During the full course, you need to take 30 tablets of Respibron. In other words, Respibron is taken in three ten-day courses for three months with two 20-day breaks between them.
When prescribing to young children: it is recommended to first make sure that the drug can be used in this form; crush the tablet, moisten it with boiled water at room temperature and place the resulting pasty mixture in the mouth.
Children
The medicine is used in children aged 2 years and older.
Overdose
There have been isolated cases of overdose, with insomnia and abdominal pain. Treatment is symptomatic.
Side effects
Skin and subcutaneous tissue disorders: allergic reactions including urticaria, pruritus, rash and oedema
Infections and invasions: rhinitis, bacterial tonsillitis, influenza.
General and injection site reactions: fever, fatigue, and headache.
Respiratory and mediastinal disorders: cough, laryngitis.
Reporting adverse reactions after the registration of a medicinal product is important. This allows monitoring of the benefit/risk ratio of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all cases of suspected adverse reactions and lack of efficacy of the medicinal product via the Automated Information System for Pharmacovigilance at the link: https://aisf.dec.gov.ua.
Expiration date
3 years.
Packaging
10 tablets in a blister, 1 or 3 blisters in a cardboard box.
Storage conditions
Store at a temperature not exceeding 25 °C in the original packaging and out of the reach of children.
Vacation category
Without a prescription.
Producer
Bruschettini s.r.l./ Bruschettini SRL
Location of the manufacturer and address of the place of implementation of its activities
Bia Isonzo 6, 16147 Genoa, Italy / Via Isonzo 6, 16147 Genova, Italy.
Applicant
Lallemand Pharma AG, Switzerland.
Location of the applicant and/or applicant's representative
Via Selva, 2, 6900 Massagno, Switzerland / Via Selva, 2, 6900 Massagno, Switzerland.
Produced for Milli Healthcare Limited, United Kingdom (+380 44 498-13-34).
