Uro-Waxom® (Uro-Vaxom®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Dosage form: & nbspcapsules
Composition:

Composition per 1 capsule:

Active substance:

lyophilized bacterial lysate Escherichia coli - 6 mg;

Excipients:

propyl gallate (anhydrous) - 0.084 mg; sodium glutamate (anhydrous) - 3.03 mg; Poloxamer 188 - 2.51 mg; simethicone, emulsion 30% - 0.396 mg; sodium chloride - 4.94 mg; mannitol up to 60.00 mg; pregelatinized starch - 77.00 mg; magnesium stearate - 3.00 mg; Mannitol - the required amount up to 200.00 mg;

shell capsule: iron oxide red (E 172) - 0.01 mg; iron oxide yellow (E 172) - 0.21 mg; titanium dioxide (E 171) - 0.87 mg (dyes); gelatin to 50.00 mg.

Description:

Hard gelatin capsule size of 3, the lid of orange color is opaque, the case of yellow color is opaque. The contents of the capsule are powder from light yellow to light brown in color.

Pharmacotherapeutic group:Immunomodulating agent
ATX: & nbsp
  • Other immunostimulants
    • Pharmacodynamics:

    The immunobiological effect of Uro-Waxom® has the following effect: stimulates T-lymphocytes; induces the formation of endogenous interferon; increases the content of immunoglobulin A (IgA), including in the urine. Uro-Vax® reduces the frequency of recurrence of urinary tract infections, in particular cystitis.

    Indications:

    Combined treatment and prevention of recurrences of chronic urinary infections pathways, especially cystitis, regardless of the nature of the microorganism, in combination with antibiotics or antiseptics in adults and children from the age of 4 years.

    Contraindications:

    Hypersensitivity to the components of the drug.

    Pregnancy and lactation:Clinical studies in pregnant women have not been conducted. Research on animals did not reveal a negative effect on the course of pregnancy, embryo development, fetus and / or postnatal development. With regard to breastfeeding Special investigations were not conducted and information on this issue to the present time is not available.
    Dosing and Administration:

    Treatment: 1 capsule daily in the morning on an empty stomach as an additional of the drug during routine antimicrobial therapy until the symptoms disappear, but not less than 10 days. The maximum duration of treatment is 3 months. Prevention of recurrences of chronic urinary tract infection: 1 capsule daily in the morning on an empty stomach for 3 months.

    In case the child is difficult to swallow the capsule, it should be opened and mixed with the drink (fruit juice, milk, etc.).

    Duration of treatment or the appointment of a second course of therapy should be determined by the doctor, based on the patient's health status.

    Side effects:

    The overall incidence of adverse events in clinical trials was about 4%.

    The table below shows the reported side effects, depending on the frequency of their occurrence:

    Frequent (from 1 to 10%)

    Infrequent (0.1 to 1%)

    Disorders from the gastrointestinal tract

    diarrhea, nausea, dyspepsia, including a feeling of discomfort in the epigastric region

    abdominal pain

    Disturbances from the nervous system

    headache

    General condition disorders

    fever

    Disturbances from the skin and subcutaneous tissue

    allergic reactions: rash, itching, unexpressed exanthema

    Single cases of serious adverse events, such as oral edema and peripheral edema, as well as the development of alopecia have been reported. When skin (in the case of isolated or unexplained fever (above 38 ° C) occurring at the beginning of the treatment) or edema should be discontinued, as these symptoms may be signs of an allergic reaction.

    Overdose:Data on cases of overdose are absent.The nature of the Uro-Vaxom® preparation and the results of studying its toxicity indicate that an overdose is unlikely.
    Interaction:

    Interactions with other drugs have not been established to date. As a precaution, do not take the drug two weeks before and within two weeks after ingestion of live vaccines. Immunosuppressive drugs can affect the effect of the drug.

    Special instructions:

    Compliance with precautions when using the drug is not required.

    Effect on the ability to drive transp. cf. and fur:Uro-Vax® does not affect the ability to drive vehicles and machinery.
    Form release / dosage:Capsules.
    Packaging:10 capsules per blister of aluminum foil and PVC / PVDC, 3 blisters per pack of cardboard together with instructions for use.
    Storage conditions:

    Store at a temperature of 15 to 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    5 years.

    Do not use after the expiration date printed on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:П N011541 / 01
    Date of registration:06.10.2011
    The owner of the registration certificate: OM Pharma SA OM Pharma SA Switzerland
    Manufacturer: & nbsp
    OM PHARMA, S.A. Switzerland
    Representation: & nbspASTELLAS PHARMA YUROP BV ASTELLAS PHARMA YUROP BV Netherlands
    Information update date: & nbsp20.11.2015
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