Composition, form of production and packaging
Capsules hard gelatinous, size 3, with an opaque orange lid and an opaque yellow body; the contents of the capsules are powder from light yellow to light brown.
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 mg, pregelatinized starch - 77 mg, magnesium stearate - 3 mg, mannitol - the required amount to 200 mg.
The composition of the capsule shell: iron oxide red (E172) - 0.01 mg, iron oxide yellow (E172) - 0.21 mg, titanium dioxide (E171) - 0.87 mg (dyes), gelatin - up to 50 mg.
10 pieces. - blisters (3) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2017.
A drug that has an immunobiological effect. Activation of the immune reaction after oral administration of the drug Uro-Waxom В® begins in the area of вЂ‹вЂ‹Peyer's patches of the small intestine. Strengthening of the immune response in the genito-urinary tract under the influence of the Uro-Vaxom В® occurs in two directions:
1. Activation of the humoral immune response (activation of T- and B-lymphocytes, synthesis of various anti-E. coli-antibodies, synthesis of immunoglobulin class A).
2. Activation of nonspecific immune response (macrophages and NK-cell phagocytosis).
Due to this activation, the Uro-Wax В® is effective against not only E. coli, but also against other uropathogens, including various E. coli serotypes and / or pathogens belonging to other genera of bacteria. In vitro studies have shown that Uro-Waxom В® stimulates the activity of macrophages and neutrophils, activates the maturation of dendritic cells and increases the expression of adhesive molecules by neutrophils. Activation and maturation of dendritic cells are the central links of the cellular response for triggering an appropriate immune response in the intestine.
Thanks to the activation of B-lymphocytes, the synthesis of immunoglobulin A increases, including. in the urine. In addition, studies in mice have shown that Uro-Waxom В® increases the leukocyte activity in the blood and the secretion of tumor necrosis factor alpha (TNF?), Interleukin-6 (IL-6), interleukin-12 (IL-12), interferon- alpha (IFN-alpha) peritoneal cells, as well as immunoglobulin G (IgG) in the culture of spleen cells. The molecular mechanism by which the Uro-WaxВ® stimulates innate immunity cells is probably related to its ability to activate image-recognition receptors (PRRs). In in vitro studies using HEK.293 cell lines with the expression of membrane and cytoplasmic image-recognition receptors (Toll-like receptors (TLRs) or Nod-like receptors (Nod)) and the presence of reporter genes, it was found that the components contained in the preparation Uro-VaxВ®, are recognized by the TLR2 and TLR4 receptors and to a lesser extent by Nod2, but are not recognized by receptors such as TLR3, TLR5, TLR7, TLR8 or TLR9. Activation of these receptors, associated with pathogen-associated molecular patterns (PAMPs), including small molecules of the bacterial wall from the composition of the drug Uro-Waxom, triggers a cascade of immune reactions.
The drug Uro-Waxom В® contributes to the following effects:
-stimulates T- and B-lymphocytes;
-stimulates the activity of dendritic cells, macrophages, NK cells and neutrophils;
-induce the formation of endogenous interferon (IFN), TNFО±, interleukin-6 (IL-6), interleukin-12 (IL-12);
- increases the content of immunoglobulin A (IgA), incl. in the urine.
Uro-Waxom В® has an immunostimulating effect and activates B-lymphocytes (production of polyclonal antibodies), macrophages (effect on phagocytosis function), and dendritic cells (activation of maturation markers).
When taking Uro-Vaxom В®, the frequency of recurrences of infections of the urinary tract, especially cystitis, decreases.
Data on the pharmacokinetics of Uro-Waxom В® are not available.
- combined treatment and prevention of recurrences of chronic urinary tract infections, especially cystitis, regardless of the nature of the microorganism, in combination with antibiotics or other antimicrobial agents in adults and children aged 4 years and older.
Treatment: 1 capsule daily in the morning on an empty stomach, washed down with water or other drinks, as an additional medicine for 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.
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.
Often (1 to 10%) Infrequently (0.1 to 1%)
From the side of the digestive system Diarrhea Nausea Dispepsia Abdominal pain
From the side of the nervous system Headache
Common Reactions Fever
From the skin and subcutaneous fat Fatigue Itch
From the side of the immune system Hypersensitivity reactions
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 reactions occur, fever (in the case of isolated or unexplained fever (above 38 В° C) occurring at the beginning of treatment) or swelling should be discontinued, because these symptoms may be signs of an allergic reaction.
- Hypersensitivity to the components of the drug.
PREGNANCY AND LACTATION
Large clinical studies in pregnant women were not conducted. There is a pilot clinical trial in pregnant women with acute urinary tract infection (n = 62; II and III trimesters of pregnancy), which demonstrates that the drug was well tolerated by the patients and that all newborns were healthy and had normal Apgar scores.
Animal studies have not shown adverse effects on pregnancy, fetal development, fetus, childbirth, and / or postnatal development. If Uro-VaxВ® is appointed in the first trimester of pregnancy, the attending physician must independently assess the benefit / risk ratio.
With regard to breastfeeding, no special studies have been conducted and there is no information on this issue to date.
APPLICATION FOR CHILDREN
Assign to the testimony of children over 4 years
In case of skin reactions, fever or swelling, treatment should be discontinued, because these phenomena can be symptoms of an allergic reaction.
Use in Pediatrics
The efficacy and safety of Uro-Wax В® was not investigated in children younger than 4 years .
Impact on the ability to drive vehicles and manage mechanisms
Uro-VaxВ® does not affect the ability to drive vehicles and machinery.
Data on cases of overdose are absent. The nature of the Uro-Vaxom В® preparation and the results of studying its toxicity on animals indicate that an overdose is unlikely.
Immunosuppressive treatment reduces or completely blocks the therapeutic effect of the drug Uro-Wax В® . Interactions with other drugs have not been established to date.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of reach of children at a temperature of 15 В° to 25 В° C. Shelf life - 5 years.