Solkotrihovak

Active material: selection inactivated lyophilized lactobacillus
When ATH: J07AX
CCF: Vaccine, regulating the balance of vaginal flora, for systemic use
ICD-10 codes (testimony): A59, N76
When CSF: 14.03.02.03
Manufacturer: VALEANT PHARMACEUTICALS SWITZERLAND GmbH (Switzerland)

Pharmaceutical form, composition and packaging

Lyophilisate for suspension for the / m in the form of porous pills of white color.

Excipients: phenol (200 g), repolimerizirovanny gelatin (gematsel) (5 mg), sodium chloride (4.5 mg).

Solvent: water d / and – 0.5 ml.

Bottles (1) together with the solvent (amp.) – packs cardboard.
Bottles (3) together with the solvent (amp.) – packs cardboard.

Pharmacological action

Vaccine, regulating the balance of vaginal flora, for systemic use. Vaccine leads to the activation of specific and non-specific immunity.

Under the action of the drug is an increase in the level of humoral IgG antibodies in response to surface antigens of atypical lactobacilli, contained in the preparation, as well as increasing the total sIgA and raising sIgA-specific antibodies in vaginal secretions. Despite, that some time after administration of the drug content of specific sIgA-antibodies is reduced to the original level, the protective effect of the drug, reduces the risk of reinfection.

In experimental studies, both in vitro and in vivo has been shown, Solkotrihovak that activates polyclonal B-lymphocytes, and also promotes the formation of non-specific IgA antibodies. In in vitro experiments, it was found increasing phagocytic activity of macrophages, against the background of vaccination Solkotrihovak animals showed a significant short-term increase of the cytotoxic activity of their own T-killers.

Development of specific and non-specific antibodies against the background of vaccination Solkotrihovak promotes elimination of atypical forms of lactobacillus, Trichomonas and nonspecific pathogenic bacteria, promotes sticks Dederleyna, restore the normal microflora and the normalization of physiological pH value of the vaginal mucosa.

Solkotrihovak Vaccination reduces the risk of recurrence of infection and re-infection, caused by Trichomonas and other pathogenic bacteria, in 80% patients with recurrent vaginal infections.

Pharmacokinetics

Pharmacokinetic studies have not been conducted drug Solkotrihovak.

Testimony

Prevention and Treatment:

- Non-specific recurrent bacterial vaginosis;

- Recurrent trichomoniasis in women.

Dosage regimen

The drug is introduced into / m (in the buttock). The course of vaccination consists of a 3 injections on 0.5 ml each (the contents of one vial) at intervals of 2 of the week. A year later carried out a one-time booster dose of 0.5 ml.

In the future, held every single revaccination 2 year.

For the preparation of vaccines must enter sterile diluent (0.5 ml water for injection) in vial, lyophilized powder containing. Dissolution takes place within a lyophilisate 30 seconds to form a uniform whitish translucent slurry without visible foreign particles. The suspension is used immediately. Before the fence suspension in the syringe bottle with the dissolved lyophilisate should be shaken.

Do not use the drug in the presence of cracks in the vial or ampoule of lyophilisate with the solvent, Fuzzy labeling, nonseparating lumps in the dissolved preparation.

Side effect

Local reactions: rarely – ill-defined erythema, swelling and pain at the injection site.

Systemic reactions: in some cases – transient increase of body temperature (40 ° C), chills, headache, fatiguability.

Contraindications

- Acute infectious diseases;

- Active tuberculosis;

- Diseases of the hematopoietic system (incl. Acute leukemia);

- Renal failure;

- Heart failure;

- Primary and secondary immunodeficiency states;

- Hypersensitivity to the drug.

Pregnancy and lactation

Solkotrihovak not recommended during pregnancy and lactation, as there is currently no clinical data on the use of the drug in this category of patients.

Cautions

Solkotrihovak should not appoint sexually transmitted diseases (gonorrhea, syphilis).

In the case of an acute course of trichomoniasis or if symptoms of bacterial vaginosis Solkotrihovak vaccination should be carried out only in combination with etiotropic treatment.

The vaccination should be calculated in such a way, to administration of the drug did not coincide with menstruation patient.

Allergic reactions using the drug were not observed. In the case of their occurrence or the development of other serious reactions should discontinue use of the drug.

All cases of post-vaccination complications must be reported to the local health department, State Institute of Standardization and Control of Medical immunobiological Preparations. L.A.Tarasevicha (119002, Moscow, Sivcev Vražek, 41) and representation of the company Valeant Pharmaceuticals Switzerland GmbH.

Use in Pediatrics

It is not recommended to prescribe a drug children under the age of 15 years, tk. currently no data on the clinical trials of the drug in children.

Effects on ability to drive vehicles and management mechanisms

Use of the drug has no effect on the ability to operate machinery and driving vehicles.

Overdose

Currently, cases of drug overdose were reported Solkotrihovak.

Drug Interactions

Against the background of immunosuppressive drugs or radiation therapy may weaken the effect Solkotrihovak.

Incompatibilities while using the drug Solkotrihovak with other drugs are not mentioned.

Pharmaceutical interaction

Do not mix in the same syringe Solkotrihovak and other drugs for parenteral use ( incl. Vaccine).

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

The drug should be stored in a dry, inaccessible to children at temperature from 15 ° to 25 ° C (thermocontainers). Shelf life – 3 year.