Uro-Vaxom capsules 6 mg blister No. 30

Instructions for Uro-Vaxom capsules 6 mg blister No. 30

Composition

active ingredient: Escherichia coli bacteria lysate;

1 capsule contains 6 mg of Escherichia coli bacterial lysate (lyophilized);

excipients: propyl gallate (E 310), monosodium glutamate, sodium chloride, poloxamer, simethicone, mannitol (E 421), pregelatinized starch, magnesium stearate, gelatin, red iron oxide (E 172), yellow iron oxide (E 172), titanium dioxide (E171).

Dosage form

Capsules.

Main physical and chemical properties: hard gelatin capsules. Orange cap, opaque. Yellow body, opaque. Capsule contents – light beige powder.

Pharmacotherapeutic group

Drugs used in urology. ATX code G04B X.

Pharmacological properties

Pharmacodynamics

Uro-Vaxom is an immunostimulating agent that has the following effects: stimulates T-lymphocytes, induces the production of endogenous interferon, and increases the content of immunoglobulin A (IgA), including in urine.

Pharmacokinetics

Data is missing.

Indication

Prevention of recurrence of chronic lower urinary tract infections. Combined treatment of acute urinary tract infections.

Contraindication

Hypersensitivity to the components of the drug.

Interaction with other medicinal products and other types of interactions

To date, there is no data on the interaction of Uro-Vaxom with other drugs.

Application features

Hypersensitivity reactions such as skin reactions, fever or swelling may occur when using Uro-Vaxom. If such reactions occur, the use of the drug should be discontinued as this may be a manifestation of allergic reactions.

Immunosuppressants may weaken or completely inhibit the effect of Uro-Vaxom.

Use during pregnancy or breastfeeding

Pregnancy

There is limited data on the use of Uro-Vaxom in pregnant women. One pilot study was conducted in a small group (n = 62) of pregnant women with acute urinary tract infections from the second trimester of pregnancy until delivery. Studies of the use of the drug in pregnant women during the first trimester of pregnancy have not been conducted. When using Uro-Vaxom during pregnancy, especially in the first trimester, the benefits of using the drug for the pregnant woman should be assessed against the potential risk to the fetus.

Breast-feeding.

There are no data on the use of the drug during breastfeeding. When using the drug Uro-Vaxom during breastfeeding, the benefit of using the drug for the mother and the potential risk to the child should be assessed.

Ability to influence reaction speed when driving vehicles or other mechanisms

There are no studies. It is unlikely that the drug affects the reaction speed when driving or using other mechanisms.

Method of administration and doses

Prevention: 1 capsule daily, in the morning on an empty stomach for 3 months.

Treatment of acute conditions: 1 capsule daily, in the morning on an empty stomach as an additional treatment during antimicrobial therapy until symptoms disappear, but not less than 10 days.

If the child has difficulty swallowing the capsule, the capsule should be opened and its contents mixed with a liquid (fruit juice, water).

Children

The drug is prescribed to children aged 4 years and older.

Overdose

No cases of overdose have been reported.

Side effects

The adverse reactions listed below are classified by system organ class and by frequency of occurrence based on data from clinical trials and/or post-marketing use.

Common: <1/10 - ≥1/100; uncommon: <1/100 - ≥1/1000; rare: <1/1000 - ≥1/10000; very rare: <1/10000, including isolated cases.

On the part of the immune system

Uncommon: hypersensitivity reactions.

Very rare: oral edema.

From the nervous system

Common: headache.

From the digestive system

Common: nausea, diarrhea, gastric discomfort, dyspepsia.

Uncommon: abdominal pain.

Skin and subcutaneous tissue disorders

Uncommon: rash, itching.

Very rare: alopecia.

General disorders and administration site conditions

Uncommon: fever.

Very rare: peripheral edema.

Expiration date

5 years.

Storage conditions

Keep out of reach of children.

Store at a temperature not exceeding 25 ºС.

Packaging

10 capsules in a blister; 3 blisters in a cardboard box.

Vacation category

According to the recipe.

Producer

OM Pharma SA, Switzerland.

Location of the manufacturer and its business address.

22, rue du Bois-du-Lan, 1217 Meyrin, Switzerland.

Applicant

OM Pharma SA, Switzerland.

Location of the applicant. 22, rue du Bois-du-Lan, 1217 Meyrin, Switzerland.