UROSTIM 25 mg for children
UROSTIM 50 mg for adults |
| |
| Composition: |
Active
substance - each tablet Urostim contains 50 mg freeze-dried
active substance or 25 mg freeze - dried active substance,
comprising killed bacterial cells of the following microbial
species: Escherichia coli 29 in quantity corresponding
to 3 x 109 bacterial cells Escherichia coli
J5 in quantity corresponding to 3 x 109
bacterial cells and Proteus mirabilis, Enterococcus faecalis,
Klebsiella pneumoniae in quantities corresponding to
0.4 x 109 cells
of each microorganism for adults, and respectively for children
Escherichia coli 29 in quantity corresponding to
1.5 x 109 bacterial cells, Escherichia coli
J5 in quantity corresponding to 1.5 x 109
bacterial cells and 0.2x109 bacterial cells of
each of the microbial species Proteus mirabilis, Enterococcus
faecalis, Klebsiella pneumoniae. It contains from 0.001
to 0.1 mg formaldehyde.
Auxilary substances, (g)
| For Urostim tablets |
50 mg |
25 mg |
| Microcrystaline
cellulose |
0.056 |
0.042 |
| Wheat
starch |
0.055 |
0.041 |
| Colloidal
silica, water-free |
0.006 |
0.003 |
| Povidon |
0.010 |
0.007 |
| Magnesium
stearate |
0.003 |
0.002 |
| Dextran
40, incorporated in the composition of the active
substance |
0.028 |
0.014 |
|
Mechanism of action: |
| Urostim
is a polybacterial immune-stimulator which enhances the
natural resistance of organisms and specific immunity towards
different infections of urological - genital tract through
stimulation of the humoral and cell factors of immune system.
It activates the system and local immunity. |
Indications: |
| Preparation
Urostim is intended for oral immune-therapy and immune-prophylactics
of acute, relapsing and chronic non-specific diseases of
urological - genital tract of children and adults despite
of the type of the causing agent. Its application is especially
preferred in cases of cystitis, pyelonephrites, uretrities,
prostatitis, asymptotic bacteriuria, etc. When necessary,
the preparation is applied in combination with antibiotic
therapy. The application of Urostim at patients with suppressed
immunological reactivity, resulting from continuous antibiotic
therapy is especially suitable. |
|
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 were observed. Clinical
results show very good tolerance. |
Medicinal Interactions: |
| No
incompatibility with other medical preparations was observed.
Urostim 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: |
| Urostim is administered in the form of tablets 50 mg for adults and
for children at age between 8 months and 14 years - tablets
of 25 mg. In acute stages of urological infections, in parallel
with the antibiotic therapy, one tablet is administered
in the morning, before meal until disappearance of the symptoms,
but not less than 10 subsequent days.
In cases of chronic and relapsing urological infections,
one tablet is administered in the morning, before meal within
2 - 3 subsequent months. At least three months interruption
of the treatment is necessary, before repeating the therapy.
For prophylactics of post-surgery manipulations, one month
before the operation and one month after the operation,
is administered one tablet Urostim daily.
The dosage and duration of treatment are prescribed by a
physician. |
|
Storage:
|
| It should be stored in dark, at temperatures below 25°C, out of reach
of children. |
Dosage and packing: |
| Tablets of 50 mg for adults,
30 tablets per package.
Tablets of 25 mg for children, 30 tablets per package. |
|
Shelf life:
|
| 24
months from the date of manufacture. Do not use the medicinal
preparation after the date of expiry, 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
|
| Last Revision: 08.08.2000 |