Instruction for use: SolcoTrichovac

Dosage form: lyophilisates for solution for intramuscular and subcutaneous administration

ATX

J07AX Other antibacterial vaccines

Pharmacological group:

Vaccines, serums, phages and toxoids

The nosological classification (ICD-10)

A59 Trichomoniasis: Trichomonas infection; Trichomoniasis; Recurrent trichomoniasis in women; Chronic trichomoniasis; Acute trichomoniasis; Chronic complicated multifocal trichomoniasis

N76 Other inflammatory diseases of the vagina and vulva: Vulvovaginitis atrophic; Vulvovaginitis bacterial; Vulvovaginitis estrogen-deficient; Bacterial vaginosis; Vaginitis; Vaginitis bacterial; Inflammatory diseases of the vagina and vulva; Inflammatory diseases of female genitalia; Inflammatory diseases of female genital organs; Vulvit; Vulvovaginitis; Vulvovaginitis; Gardnerella; Fungal vulvovaginitis in girls and virgins; Infection of the vagina; Infection of the genitals; Colpitis; Violation of purity of the vaginal secretion; Nonspecific cervicovaginitis; Nonspecific vulvitis; Nonspecific vulvovaginitis; Nonspecific colpitis; Recurrent nonspecific bacterial vaginosis; Senylic coverings; Mixed Colpus; Chronic vaginitis; Vulvovaginal infections; Bacterial vaginitis; Bacterial vaginosis; Bacterial vaginitis; Mixed vaginal infections

Composition and release form

Lyophilisate for suspension for injection 1 dose

Inactivated lyophilized microorganisms of the strain of acidophilic lactobacilli (Lactobacillus acidophilus) not less than 7 · 109

Excipients: phenol (preservative) - 0.2 mg; repolimerizirovanny gelatin (gematsel) - 5 mg; sodium chloride - 4.5 mg

In vials (1 inoculation dose) complete with a solvent in ampoules (0.5 ml of water for injection); in the box 1, or 3 sets.

Description of dosage form

A porous tablet of a lyophilized dried substance of white color. When dissolved in water for injection, a matte translucent slurry is formed.

Pharmachologic effect

Mode of action - Antibacterial, immunostimulating, normalizing the microflora of the vagina.

Vaccination Solko Trichovac leads to the activation of specific and nonspecific immunological reactions of the body.

Activation of specific immunity

The use of SolcoTrichovac results in an increase in the content of humoral antibodies of IgG class to surface antigens of lactobacilli, an increase in total sIgA, and an increase in the level of specific sIgA antibodies in the secretion of the vagina. Although the content of specific sIgA antibodies is reduced to the initial level after a short time after the administration of the drug, the protective effect of the drug that reduces the risk of re-infection remains.

Activation of nonspecific immunity

In in vitro and in vivo experiments, it has been shown that the use of SolcoTrichovac activates polyclonal B-lymphocytes, and also stimulates the formation of non-specific IgA antibodies. In experiments in vitro, a significant short-term increase in the phagocytic activity of macrophages, as well as the cytotoxic activity of T lymphocytes, was observed in the study of biological materials obtained from animals vaccinated with SolcoTrichovac.

Mobilization of specific and nonspecific immunological reactions of the organism against the background of vaccination with SolcoTrichovac is directed against the antigens contained in the preparation (H2O2-negative strains of lactobacilli), which contributes to the elimination of atypical forms of lactobacilli, the growth of Doderlein's physiological rods and, as a result, to normal microflora recovery and physiological pH normalization The mucous membrane of the vagina.

Vaccination SolkoTrichovac not only stabilizes the vaginal microenvironment, but also prevents the risk of recurrence and reinfection in 80% of patients with recurrent vaginal infections.

Indication of the drug SolcoTrichovac

Prophylaxis and treatment of recurrent nonspecific bacterial vaginosis and recurrent trichomoniasis in women.

Contraindications

Hypersensitivity to the drug components, acute infectious diseases, acute tuberculosis, diseases of the hematopoietic system (acute leukemia, etc.), heart and kidney disease with decompensation phenomena, diseases of the immune system (HIV).

Application of pregnancy and breastfeeding

Until now, clinical trial data regarding the use of SolcoTrichovac during pregnancy and breastfeeding 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.

Side effects

Rarely - local reactions 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.

Interaction

It is not recommended to mix SolcoTrichovac and other parenteral drugs and vaccines in the same syringe.

Dosing and Administration

IM. The course of vaccination consists of 3 injections 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 menstrual cycle of the patient.

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.

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 s. Ready-to-use suspension should be homogeneous. The prepared suspension is used immediately. Before taking the suspension in a syringe, the vial should be shaken.

Precaution measures

In the case of acute trichomoniasis, SolcoTrichovac should be vaccinated only after preliminary etiotropic treatment. The drug should not be prescribed for sexually transmitted diseases (gonorrhea, syphilis). The use of the drug in children under 15 years is possible in case of emergency, when the expected therapeutic effect exceeds the risk of possible side effects (clinical trial data are not available). Against the background of treatment with immunosuppressants and / or during radiation therapy, partial or total loss of efficacy of SolcoTrichovac may be observed. Do not use the drug in the presence of cracks in the vial with lyophilizate or on the ampoule with water for injection, with fuzzy labeling, with a violation of the physical properties of the dissolved drug. The drug does not affect the ability to work with machinery and driving vehicles.

Manufacturer

IS CN Pharmaceuticals Switzerland Ltd .; Manufactured by ICN En Switzerland AG.

Storage conditions of the drug SolcoTrichovac

In a dry place, at a temperature of 15-25 ° C.

Keep out of the reach of children.

Shelf life of the drug SolcoTrichovac

3 years.

Do not use after the expiry date printed on the package.