Uro-Vaxom Om Pharma drug enhances immunity caused by urinary tract infections (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Escherichia Coli Escherichia Escherichia

Ingredient

Composition information	Content
Escherichia Coli Escherichia Escherichia	6mg

Uses

indications

Uro-faxom drugs are indicated in the following cases:

Treatment of immunity in the prevention of low urinary tract infections and treatment support for acute urinary tract infections.

Pharmacokology

Mechanism of action

The main active ingredient of Uro-Vaxom (OM-89) is the soluble extract of 18 strains of E.coli bacteria used for recurrent urinary infections. In accordance with the efficiency of the useful natural immune regulation of the bacteria that survive in the intestinal tract, OM-89 promotes signs of immunotherapy and activates congenital immunity and immunity.

Dual response increases the effectiveness of the immune system, resulting in enhancing protection against urinary tract infections. This effect is general (ie increased cells), cell immunity (stimulating B and T cells) and epidemic immunity (creating antibodies and inflammatory cytokine). This soluble bacterial extract is produced by controlled chemicals, resulting in the formation of low molecular immune receptors and resistance against digestive proteases.

OM-89 treatment effect is most clearly explained by the natural stimulation of the immune system in the intestinal tract, taking place in Peyer (PPS) arrays, as shown by the segments that are enriched and labeled 14C in these immune structures.

OM-89 is a immune transformer, according to the natural immune response mechanism, absorbed in the intestine, where it creates immune cells in the lymphatic tissue in the intestine and then enhances the mucosal immunity in the urinary tract.

Effective/clinical research

published four short -term studies, with a double blind Placebo in healthy adults with urinary tract infections, in addition to a study in a special population (patients with spinal damage) and some open -label tests. These studies have confirmed the clinical relevance of the above -mentioned immunology findings.

also learned the long-term effects when using Uro-Vaxom, including a double blind study as well as the effect of intensified dose. A few open label studies are conducted in children, pregnant women and after menopause.

Dynamic pharmacokinetics

There is no pharmacokinetics research conducted on humans.

Clinical properties:

animal pharmacokinetics research

absorption

Give white rats a single dose of E.coli extract 14C (from one strain) (> 30 KD). This study shows that the 50% absorption of segment is characterized by at least 30 KD molecules. After drinking, the peak concentration in plasma is achieved after 4 hours and the average selling time in plasma is about 33 hours.

After absorbing through the mucosa, the segments contained in OM-89 will come into contact with the immunosuppressive cells of the intestinal tract (as in the Peyer segment). This ensures an appropriate stimulation to achieve the immune system effects.

Distribution

Give white rats a single dose of E. Coli extract and compare with high molecular oral doses (> 30 KD) and low (

Give white rats a single dose OM-89 high molecule> 30 KD. The highest merger of the marker is found in the liver, endocrine glands (adrenal, I say, pancreas), and in lymphatic tissues (spleen, intestinal lymph nodes).

Metabolism

Give white rats with a single dose of OM-89 14C high molecule> 30 KD. Analysis by chromatography eliminates the size of 14C markers in the serum 4 hours after drinking, showing a very small change in the high molecular model of the initial segment for lower volume molecules. This shows that the radioactive substance in the serum originates from HEC extract, and part of this marking substance is also found in molecules with high molecules.

Immune precipitate tests show that the antigen symbols of OM-89 14C> 30KD are retained at least partially during the process of digestion and absorption; The ratio of radioactive percentage 14C-OM-89> 30KD obtained in white rat serum shows that at least one part of the OM-89 product (or its segments) is attached to specific immune globulin for E. Coli OM-89 extract, while the rest exists in the form of freedom.

Elimination

The amount of radioactivity is mainly excreted within 24 hours. At 96 hours, the test reactor was excreted mainly in feces (male: 51.0% ± 3.5; female: 50.9% ± 4.2), followed by exhaled gas (male: 22.6% ± 0.3, female: 25.0% ± 3.1) and urine (male: 3.9% ± 1, female: 4.1% ± 0.6), total of 78.3% (± 2.6%) 6.1) Of the total OM-89> 30 KD used.

A low or negligible rate has been found in the intestinal tract and stomach. A total of 90.6% (in men) has been detected and 91.5% (in women) of the 14C marker.

Data on preclinical safety

OM-89 shows significant safety in the expansion programs of animal safety research.

Before taking Uro-Vaxom Om Pharma drug enhances immunity caused by urinary tract infections (3 blisters x 10 tablets)

How to use

oral tablets. Take the tablet with a glass of water. Dosage

Preventive or supplement treatment: 1 tablet 6mg a day, drink in the morning when hungry for 3 consecutive months.

Treatment of urinary tract infections: 1 tablet 6mg 1 day, drink in the morning when hungry to support the treatment of common bacterial infections until the symptoms are over but at least for 10 consecutive days.

Specific dose recommended:

Children: The safety and effectiveness of Uro-Vaxom has not been studied in children under 4 years old.

Elderly: No need to adjust the dose due to age.

Patients with liver or renal failure: There is no specific data on the safety and effectiveness of Uro-Vaxom in patients with liver or kidney failure. Therefore, there is no recommended dose for this patient.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.What do

do when using overdose?

Management

Actively monitor for timely management measures.

In case of emergency, call the 115 emergency center immediately or go to the nearest local health station.

What to do when you forget 1 dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double doses to compensate for missed dose.

Side Effects

When using Uro-Vaxom drugs you may experience unwanted effects (ADR):

Unwanted effects are shown by the organs and the frequency they are observed in clinical trials and / or in the actual monitoring process during URO-Vaxom use. The frequency is determined as follows:

Common:

immune system disorders

Less: hypersensitivity.

Common: headache

Common: Nausea, diarrhea, stomach intolerance, indigestion.

Uncommon: rash, itching.

Very rare: Hair loss.

Uncommon: Fever.

Very rare: External edema.

Notify the physician with unwanted effects when using the drug.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

contraindicated

URO-VAXOM drug contraindicated in the following cases:

Hypersensitivity to any ingredient of the drug.

Be cautious when using

need to be very careful when taking the drug for patients in the following cases:

Uro-Vaxom can cause hypersensitivity reactions such as skin reactions, fever or edema. In this case, it is necessary to stop treating because there may be allergic reactions.

The effect of the drug on the ability to drive and operate machinery

unknown effects of the drug.

Use drugs for women during pregnancy and lactation

Pregnant women

There are very little data on Uro-Vaxom use in pregnant women.

A pilot study was conducted with a small group of pregnant women (n = 62) with acute urinary tract infection (UTI) throughout the second quarter of pregnancy until birth.

There are no studies conducted in women in the first 3 months of pregnancy.

Uro-Vaxom should only be used during pregnancy when benefits bring higher risks. This is especially true in the first quarter of pregnancy.

breastfeeding women

Because no data is available, Uro-Vaxom should be used during breastfeeding after careful assessment of risk/benefits.

Drug interaction

currently has no drug interactions have been recorded.

Storage

Leave a cool place, avoid light, temperature below 30⁰C.

To be out of reach of children, read the user manual carefully before use.

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