Respivax immune-prophylactic of respiratory system

Respivax polybacterial immunostimulator 30 tabl x 25 mg # 45201 PB(3,5)

Respivax polybacterial immunostimulator 30 tabl x 50 mg # 45202 PB(3,5)

Respivax 25 mg for children and 50 mg for adults

Respivax Composition:

Active substance - each tablet contains 25 mg freeze-dried active substance for children and 50 mg freeze - dried active substance for adults, comprising freeze-dried killed bacterial cultures of the following microbial species: Streptococcus pneumoniae, Branhamella catarrhalis, Streptococcus pyogenes of group A, Haemophilus influenzae type b, Sraphylococcus aureus, Klebsiella pneumoniae in quantities corresponding to 0.625x109 cells of each microorganism for children and 1.25x109 cells of each microorganism for adults. It contains from 0.001 to 0.1 mg formaldehyde.

Auxilary substances, (g)

For Respivax tablets	25 mg	50 mg
Microcrystaline cellulose	0.052	0.066
Wheat starch	0.051	0.065
Colloidal silica, water-free	0.003	0.006
Povidon	0.007	0.010
Magnesium stearate	0.002	0.003
Dextran 40, incorporated in the composition of the active substance	0.015	0.030

Rrespivax Mechanism of action:

The preparation is a polybacterial immune-stimulator which enhances the natural resistance of organisms and specific immunity towards different respiratory infections through stimulation of the humoral and cell factors of immune system. It has a proven stimulative effect on the cells of the immune system of intestines and mesentery, and in significant degree on the lymphoid formations in the lungs, situated peri-bronchially.

Respivax Indications:

The RESPIVAX preparation is intended for oral administration with aim immune-therapy and immune-prophylactics of non-specific diseases of respiratory system and it has a very good effect during treatment of children and adults, suffering from often repeated and chronic respiratory infections:

• acute bronchitis and trachea-bronchitis;
• chronic and relapsing bronchitis and trachea-bronchitis;
• acute and chronic tonsillitis, pharyngitis and laryngitis;
• acute and chronic rhinitis, sinusitis and othitis;
• often repeated bronchopneumonia;
• infections of respiratory system, resistant to antibiotic therapy;
• infections of respiratory system, accompanied with hyper sensitivity to antibiotics or other chimiotherapeutics;
• infectious bronchial asthma.

It is application is especially suitable at patients with allergies to antibiotics or at infections caused by bacteria, resistant to antibiotics. The application of RESPIVAX during the autumn-winter period is extremely appropriate before and during influenza epidemics, when its prophylactic and treatment effect regarding the developing secondary bacterial infections is distinctly favourable.

Repivax Contraindications:

It is contraindicative in the cases of auto-immune diseases with an increased synthesis of antibodies.

Undesirable Medical Reactions:

Till now no undesirable medicinal reactions after application of RESPIVAX were observed. Clinical results show very good tolerance by the organisms.

Medicinal Interactions:

No incompatibility with other medical preparations were observed. RESPIVAX can be combined with any other treatment, including antibiotic therapy. It allows several fold application without gaining resistance.

Precautions and special warnings for administration:

Application of the preparation during the first three months of pregnancy is not recommended. The preparation contains wheat starch which could be hazardous for people suffering from ceauliaceae.

Dosage and administration:

For the purposes of immune-therapy and immune-prophylactics, RESPIVAX for adult at daily dose of 50 mg and for children from 3 to 14 years daily dose of 25 mg is applied.

RESPIVAX is administered in the following way:

TREATMENT (IMMUNE-THERAPY):

Within 30 days, one tablet is administered in the morning, before meal. Supporting course of treatment - for achieving long effect of the treatment, administration of 1 tablet RESPIVAX in the morning before meal within 20 successive days in three subsequent months is recommended. This course of treatment can be repeated again after 5 - 6 months.

Under prescription of a doctor, in cases of significant suppression of immune system resulting from different diseases, including malignant ones, the treatment could be prolonged and 1 tablet RESPIVAX is administrated in the morning before meal without interruption of the treatment of the patients for 3 - 6 months.

PROPHYLACTIC COURSE (IMMUNE-PROPHYLACTICS):

One tablet RESPIVAX daily, in the morning before eating within 20 days in 3 subsequent months is administered. Starting prophylactics in October is recommended. The dosage and duration of treatment is prescribed by the doctor.

Storage:

RESPIVAX should be stored in dark, at temperatures below 25°C, out of reach of children.

Dosage and packing:

Tablets of 25 mg for children, 30 tablets per package.
Tablets of 50 mg for adults, 30 tablets per package.

Shelf life:

30 months from the date of manufacture. The medicinal preparation should not be used after the shelf life, indicated on the package.

Warnings for undergone changes:

The tablets are white to pale brown with mosaic structure. Tablets with changed appearance, cracked and/or broken should not be used.

Name and address of manufacturer:
BB-NCIPD Ltd., Bulgaria
1504 Sofia, 26 Yanko Sakazov Blvd.
Tel.: +359 2 944 61 91
Fax: +359 2 943 30 75
E-mail: bulbio@bulbio.com