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Bul Bio - National Center of Infectious and Parasitic Diseases Ltd. (BB-NCIPD Ltd.)
Urostim polybacterial immunostimulator 30 tabl x 25 mg # 452-03 PB(3,5)
Urostim polybacterial immunostimulator 30 tabl x 50 mg # 452-04 PB(3,5)
Urostim 25 mg for children
Urostim 50 mg for adults
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||25 mg||50 mg|
|Colloidal silica, water-free||0.003||0.006|
|Dextran 40, incorporated in the composition of the active substance||0.014||0.028|
Urostim 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.
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.
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.
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.
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.
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: firstname.lastname@example.org