URO-VAXOM

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT URO-VAXOM (URO-VAXOM®)

Composition:

Active substance: lysate of Escherichia coli bacteria;

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

Excipients: propyl gallate (E 310), sodium glutamate, sodium chloride, poloxamer, simethicone, mannitol (E 421), pregelatinized starch, magnesium stearate, gelatin, iron oxide red (E 172), iron oxide yellow (E 172), titanium dioxide (E 171).

Pharmaceutical form. Capsules.

Main physicochemical properties: hard gelatin capsules. Cap is orange-colored, opaque. Body is yellow-colored, opaque. Capsule contents – light beige-colored powder.

Pharmacotherapeutic group. Agents used in urology. ATC code G04BX.

Pharmacological properties.

Pharmacodynamics.

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

Pharmacokinetics.

Data not available.

Clinical characteristics.

Indications.

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

Contraindications.

Hypersensitivity to the components of the drug.

Interaction with other medicinal products and other forms of interactions.

Currently, there are no data available regarding interactions between Uro-Vaxom and other medicinal products.

Special precautions for use

When using Uro-Vaxom, hypersensitivity reactions such as skin reactions, fever, or swelling may occur. If such reactions occur, administration of the drug should be discontinued, as these may be manifestations of allergic reactions.

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

Use during pregnancy or breastfeeding.

Pregnancy

The amount of data on the use of Uro-Vaxom in pregnant women is limited. One pilot study has been conducted involving a small group (n = 62) of pregnant women with acute urinary tract infections, starting from the second trimester of pregnancy until delivery. Studies on the use of the drug during the first trimester of pregnancy have not been conducted. When using Uro-Vaxom during pregnancy, especially in the first trimester, the benefit of the drug for the pregnant woman and the potential risk for the fetus should be carefully evaluated.

Breastfeeding

There are no data available on the use of the drug during breastfeeding. When using Uro-Vaxom during breastfeeding, the benefit of the drug for the mother and the potential risk for the infant should be carefully evaluated.

Ability to affect reaction speed when driving vehicles or operating machinery.

No studies have been conducted. It is unlikely that the drug affects the ability to drive vehicles or operate machinery.

Dosage and Administration.

Prophylaxis: 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 adjunct to antimicrobial therapy until symptoms disappear, but for no less than 10 days.

If a 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 indicated for children aged 4 years and older.

Overdose.

No cases of overdose have been reported.

Adverse Reactions

The adverse reactions listed below are classified by organ systems and frequency of occurrence according to data from clinical trials and/or post-marketing use.

Common: ≥1/100 to <1/10;
Uncommon: ≥1/1,000 to <1/100;
Rare: ≥1/10,000 to <1/1,000;
Very rare: <1/10,000, including individual cases.

Immune system disorders

Uncommon: hypersensitivity reactions.

Very rare: oral cavity swelling.

Nervous system disorders

Common: headache.

Gastrointestinal disorders

Common: nausea, diarrhea, gastric discomfort, dyspepsia.

Uncommon: abdominal pain.

Skin and subcutaneous tissue disorders

Uncommon: rash, pruritus.

Very rare: alopecia.

General disorders and administration site conditions

Uncommon: fever.

Very rare: peripheral edema.

Shelf life: 5 years.

Storage conditions: Keep out of reach and sight of children.

Store at a temperature not exceeding 25 °C.

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

Prescription category: Prescription only.

Manufacturer: OM Pharma SA, Switzerland / OM Pharma SA, Switzerland.

Manufacturer's address:
22, rue du Bois-du-Lan, 1217 Meyrin, Switzerland / 22, rue du Bois-du-Lan, 1217 Meyrin, Switzerland.

Marketing Authorization Holder: OM Pharma SA, Switzerland / OM Pharma SA, Switzerland.

Address of the Marketing Authorization Holder:
22, rue du Bois-du-Lan, 1217 Meyrin, Switzerland / 22, rue du Bois-du-Lan, 1217 Meyrin, Switzerland.