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RESPIVAX 25mg. 30 tablets FOR CHILDREN / RESPIVAX

Bul Bio NCZPB EOOD

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RESPIVAX 25mg Composition:

Drug substance: Each tablet contains 25 mg lyophilised drug substance for children and 50 mg lyophilized drug substance for adults composed of lyophilized killed bacterial cultures of the following microbial species: Streptococcus pneumoniae, Branhamella catarrhal, Streptococcus pyogemophus type A group Klebsiella pneumoniae in quantities corresponding to 0.625x109 cells of each species for children and 1.25x109 cells of each species for adults.

It contains from 0.001 to 0.1 mg of formaldehyde.

Excipients in

For Respivax® tablets 25mg 50mg

Microcrystalline cellulose 0.052 0.066

Wheat starch 0.051 0.065

Colloidal silicon

anhydrous dioxide 0.003 0.006

Povidone 0.007 0.010

Magnesium stearate 0.002 0.003

Dextran 40 is included in 0.015 0.030

the composition of the drug substance

RESPIVAX 25mg Mechanism of action:

The drug is a polybacterial immunostimulant that increases the body's natural resistance and specific immunity to various respiratory infections by stimulating the humoral and cellular factors of the immune system. It has a proven stimulating effect on the cells of the immune system of the intestine and mesentery and to a significant extent on the lymphoid formations in the lung located peribronchially.

RESPIVAX 25mg Indications:

The drug RESPIVAX is intended for oral immunotherapy and immunoprophylaxis of "non-specific diseases of the respiratory system and has a very good effect in the treatment of children and adults suffering from recurrent and chronic respiratory infections:

- acute bronchitis and tracheobronchitis;

- chronic and recurrent bronchitis and tracheobronchitis;

- acute and chronic tonsillitis, pharyngitis and laryngitis;

- acute and chronic rhinitis, sinusitis and otitis;

- frequent recurrent bronchopneumonia;

- infections of the respiratory system resistant to antibiotic therapy;

respiratory tract infections accompanied by hypersensitivity to antibiotics or other chemotherapeutic agents;

- infectious bronchial asthma.

It is especially suitable for patients with allergies to antibiotics or for infections caused by bacteria resistant to antibiotics.

The use of RESPIVAX in the autumn-winter period is very appropriate before or during influenza epidemics, when its prophylactic or therapeutic effect on developing secondary bacterial infections is markedly favorable.

Contraindications:

It is contraindicated in cases of autoimmune diseases with increased antibody synthesis.

Side effects:

To date, no adverse reactions have been observed after administration of RESPIVAX®. Clinical results show very good tolerability.

Drug interactions:

No incompatibility with other drugs was observed.

RESPIVAX can be combined with any other treatment, including antibiotic therapy. Allows repeated application without danger of habituation.

Precautions and special warnings for use:

It is not recommended to use during the first three months of pregnancy. The preparation contains wheat starch which can be dangerous for people with celiac disease.

Dosage:

For the purposes of immunotherapy and immunoprophylaxis, RESPIVAX for adults daily dose 50 mg is used; for children from 3 to 14 years a daily dose of 25mg.

RESPIVAX is administered as follows:

Treatment course (immunotherapy): For 30 days 1 tablet daily, in the morning on an empty stomach; maintenance course of treatment - to achieve a lasting effect of treatment, it is recommended to take 1 tablet of RESPIVAX® in the morning on an empty stomach for 20 consecutive days in 3 consecutive months. This course of treatment can be repeated after 5-6 months. At the discretion of the attending physician and in cases of significant suppression of the immune system as a result of various diseases, including and malignant, the course of treatment can be extended, as patients take RESPIVAX® 1 tablet in the morning on an empty stomach without interruption for 3-6 months.

Prophylactic course (immunoprophylaxis): One tablet of RESPIVAX® daily, in the morning on an empty stomach for 20 days in 3 consecutive months. It is recommended that prevention begin in October.

The dosage and duration of treatment are determined by your doctor.

Manufacturer: Bul Bio NCZPB EOOD