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Dosage form: & nbspLyophilizate for suspension for intramuscular administration.
Composition:SOLKOTRIHOVAK is a lyophilized dried inactivated strain of lactobacilli.
A single dose of SOLKOTRIHOVAK (1 vial) contains:
not less than 7 х109 inactivated bacteria 8 strains of Lactobacillus in the equivalent amount: L. rhamnosus (3 strains), L. vaginalis (3 strains), L. fermentum (1 strain), L. salivarius (1 strain);
phenol (preservative) 0.2 mg
repolymerized gelatin (haemacel) 5.0 mg
sodium chloride 4.5 mg
Description:A porous tablet of a lyophilized dried substance of white color.
Pharmacotherapeutic group:MIBP is a vaccine.
ATX: & nbsp
  • Vaccines
  • Pharmacodynamics:Immunological properties
    Vaccination SOLKOTRIHOVAKOM leads to the activation of specific and nonspecific immunological reactions of the body.
    Activation of specific immunity.
    The use of SOLKOTRIHOVAK results in an increase in the content of humoral antibodies of the IgG class to the surface antigens of lactobacilli, an increase in total slgA, and an increase in the level of specific slgA antibodies in the secretion of the vagina. Despite the fact that some time after the administration of the drug, the content of specific slgA antibodies is reduced to the initial level, the protective effect of the drug, which reduces the risk of re-infection,is retained.
    Activation of nonspecific immunity.
    In experiments in vitro and in vivo, it has been shown that the use of SOLKOTRIHOVAK activates polyclonal B-lymphocytes, and also stimulates the formation of non-specific IgA antibodies. In in vitro experiments in the study of biological materials derived from animals subjected to vaccination Solkotrihovak, significant short-term increase of the phagocytic activity of macrophages was detected, and - the cytotoxic activity of T lymphocytes.
    Mobilization of specific and nonspecific immunological reactions of the body against vaccination with SOLKOTRIHOVAK is directed against the antigens contained in the preparation (H2O2 -negative strains of lactobacilli) that promotes the elimination of atypical forms lactobacilli increase in the number of rods Doderlein and as a result, restoration of the normal microflora and normalization of the vaginal mucosa pH values.
    Vaccination Solkotrihovak not only stabilize vaginal flora, but also prevents the risk of relapse and re-infection in 80% of patients with recurrent vaginal infections.
    Indications:Prevention and treatment:
    - recurrent bacterial vaginosis
    - recurrent trichomoniasis in women
    Contraindications:- acute infectious diseases
    - active tuberculosis
    - diseases of the hematopoietic system (acute leukemia, etc.)
    - heart and kidney disease with decompensation phenomena
    - the state of primary and secondary immunodeficiency
    - hypersensitivity to the components of the drug
    Dosing and Administration:To prepare the ready-to-use vaccine, the contents of the ampoule with the solvent (0.5 ml of water for injection) with a sterile syringe are introduced into the vial containing the lyophilized preparation.
    Dissolution of the lyophilizate occurs within 30 seconds. with the formation of a homogeneous translucent whitish suspension without visible foreign particles.
    The prepared suspension is used immediately. Before taking the suspension in a syringe, the vial should be shaken;
    SOLKOTRIHOVAK enter intramuscularly, in the outer upper quadrant of the gluteus muscle. The vaccination course consists of 3 injections of the drug in a single dose of 0.5 ml (the contents of 1 bottle) with an interval between injections in 2 weeks. The time of vaccination should be calculated in such a way that the administration of the drug does not coincide with the patient's menses.
    After 1 year, a single booster dose of 0.5 ml is given.
    In the future, one-time revaccination is carried out every 2 years.
    Side effects:In rare cases, local reactions develop in the form of redness, swelling and pain at the injection site.
    In some cases, general reactions are possible: a short-term increase in body temperature (up to 40 ° C), chills, headache, fatigue. If serious reactions develop after administration of the drug, its use should be discontinued.
    Allergic reactions when using the drug were not observed. In case of their occurrence, the use of the drug is stopped.
    Overdose:Not installed.
    Interaction:There have been no incidents of incompatibility of SOLKOTRIHOVAK with other drugs or vaccines with simultaneous applications.
    It is not recommended to mix SOLKOTRIHOVAK and other parenteral drugs and vaccines in the same syringe.
    Special instructions:- in the case of acute trichomoniasis or expressed symptoms of bacterial vaginosis, SOLKOTRYHOVAK vaccination should be given only in combination with etiotropic treatment;
    - SOLKOTRIHOVAK should not be prescribed for venereal diseases (gonorrhea, syphilis);
    - it is not recommended to appoint children under 15;
    - So far, clinical trial data regarding the use of SOLKOTRYHOVAK during pregnancy and lactation are not available, so the use of the drug in relation to these categories of patients is possible if the intended benefit for the mother exceeds the possible risk to the fetus;
    - against the background of treatment with immunosuppressants and / or during radiation therapy, partial or total loss of SOLKOTRIHOVAK's effectiveness may be observed;
    - the use of the drug does not affect the ability to work with machinery and driving vehicles;
    - do not use the drug in the presence of visible mechanical damage to the vial with lyophilizate or ampoule with water for injection, with fuzzy labeling, with a violation of the physical properties of the dissolved drug.
    Effect on the ability to drive transp. cf. and fur:The use of the drug does not affect the ability to work with machinery and driving vehicles.
    Form release / dosage:Lyophilizate for suspension for intramuscular administration.
    Packaging:The preparation SOLKOTRIHOVAK has 2 forms of release:
    1. Form of release, intended for primary (primary) vaccination.
    3 vials with SOLKOTRIHOVAK diofilizatom complete with 3 ampoules with a solvent (0.5 ml of water for injections) are placed in a contour mesh box of transparent plastic, which, together with the instruction for use, is placed in a cardboard box.
    2. Release form, intended for revaccination.
    1 bottle with SOLKOTRIHOVAK lyophilizate, complete with 1 ampoule with a solvent (0.5 ml of water for injection), is placed in a contoured cellular package of transparent plastic, which, together with the instruction for use, is placed in a cardboard box.
    Storage conditions:The drug should be stored in a dry place at a temperature of 15 to 25 ° C.
    Keep out of the reach of children!
    Shelf life:3 years.
    Do not use the product after the expiry date printed on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:П N015977 / 01
    Date of registration:30.09.2009
    Expiration Date:Unlimited
    Date of cancellation:2018-02-06
    The owner of the registration certificate:Valant Pharmaceuticals Switzerland GmbHValant Pharmaceuticals Switzerland GmbH Switzerland
    Manufacturer: & nbsp
    Information update date: & nbsp06.02.2018
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