RESPIVAX 25 mg for children
RESPIVAX 50 mg for adults |
| |
| 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 |
|
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. |
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. |
|
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. l
|
|
Shelf life:
|
| 30
months from the date of manufacture. The medicinal preparation
should not be used after the shelf life, indicated on the
package.l |
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
|
| Last Revision: 08.08.2000 |