Solcotrichovac (Lyophilisate) Instructions for Use

Marketing Authorization Holder

Valeant Pharmaceuticals Switzerland GmbH (Switzerland)

Manufactured By

IDT Biologika, GmbH (Germany)

Packaged By

LEGACY PHARMACEUTICALS SWITZERLAND, GmbH (Switzerland)

ATC Code

J07AX (Other bacterial vaccines)

Dosage Form

Solcotrichovac

Lyophilisate for the preparation of suspension for intramuscular administration: fl. 3 or 1 pc. in a set with solvent (amp. 0.5 ml)

Dosage Form, Packaging, and Composition

Lyophilisate for the preparation of suspension for intramuscular administration in the form of a white porous tablet.

Excipients : phenol (200 µg), repolymerized gelatin (hemacel) (5 mg), sodium chloride (4.5 mg).

Solvent water for injections – 0.5 ml.

Vials (1) in a set with solvent (amp.) – cardboard packs.
Vials (3) in a set with solvent (amp.) – cardboard packs.

Clinical-Pharmacological Group

Vaccine regulating the balance of vaginal microflora, for systemic use

Pharmacotherapeutic Group

MIBP-vaccine

Pharmacological Action

Vaccine regulating the balance of vaginal microflora, for systemic use. Administration of the vaccine leads to activation of specific and nonspecific immunity.

Under the action of the drug, an increase in the level of humoral antibodies of the IgG class occurs in response to the introduction of surface antigens of atypical lactobacilli contained in the drug, as well as an increase in the total content of sIgA and an increase in the level of specific sIgA antibodies in the vaginal secretion.

Despite the fact that some time after the administration of the drug the content of specific sIgA antibodies decreases to the initial level, the protective effect of the drug remains, reducing the risk of reinfection.

In experimental studies in vitro and in vivo, it was shown that Solcotrichovac activates polyclonal B-lymphocytes, and also stimulates the formation of nonspecific antibodies of the IgA class.

In experiments in vitro, an increase in the phagocytic activity of macrophages was detected; against the background of vaccination with Solcotrichovac in animals, a significant short-term increase in the cytotoxic activity of natural T-killers was noted.

The production of specific and nonspecific antibodies against the background of vaccination with Solcotrichovac contributes to the elimination of atypical forms of lactobacilli, trichomonads and nonspecific pathogenic bacteria, promotes the growth of Doderlein’s bacilli, restoration of normal microflora and normalization of the physiological pH value of the vaginal mucosa.

Vaccination with Solcotrichovac reduces the risk of recurrence of infection and reinfection caused by Trichomonas and other pathogenic bacteria in 80% of patients with recurrent vaginal infections.

Pharmacokinetics

Pharmacokinetic studies of the drug Solcotrichovac have not been conducted.

Indications

Prevention and treatment

• Recurrent nonspecific bacterial vaginosis;
• Recurrent trichomoniasis in women.

ICD codes

Dosage Regimen

The drug is administered intramuscularly (into the gluteal muscle). The vaccination course consists of 3 injections of the drug, 0.5 ml each (the contents of one vial) at intervals of 2 weeks.

A single revaccination with a dose of 0.5 ml is carried out after one year. Subsequently, a single revaccination is carried out every 2 years.

To prepare the vaccine, it is necessary to introduce a sterile solvent (0.5 ml of water for injections) into the vial containing the lyophilized powder.

Dissolution of the lyophilisate occurs within 30 seconds with the formation of a homogeneous, semi-transparent, whitish suspension without visible foreign particles. The prepared suspension should be used immediately. Before drawing the suspension into the syringe, the vial with the dissolved lyophilisate should be shaken.

The drug should not be used if there is a crack on the vial with the lyophilisate or on the ampoule with the solvent, unclear marking, or non-dispersible lumps in the dissolved drug.

Adverse Reactions

Local reactions rarely – mild erythema, swelling and pain at the injection site.

Systemic reactions in some cases – short-term increase in body temperature (up to 40°C (104°F)), chills, headache, fatigue.

Contraindications

• Acute infectious diseases;
• Active tuberculosis;
• Diseases of the hematopoietic system (including acute leukemia);
• Renal failure;
• Heart failure;
• Primary and secondary immunodeficiency states;
• Hypersensitivity to the components of the drug.

Use in Pregnancy and Lactation

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

Use in Renal Impairment

Contraindicated in renal failure.

Pediatric Use

It is not recommended to prescribe the drug to children under 15 years of age, because there are currently no data from clinical trials of the drug in children.

Special Precautions

Solcotrichovac should not be prescribed for venereal diseases (gonorrhea, syphilis).

In case of acute course of trichomoniasis or severe symptoms of bacterial vaginosis, vaccination with Solcotrichovac should be carried out only in combination with etiotropic treatment.

The vaccination time should be calculated so that the administration of the drug does not coincide with the patient’s menstruation.

Allergic reactions when using the drug have not been observed. If they appear or other serious reactions develop, the use of the drug should be discontinued.

All cases of post-vaccination complications must be reported to the local health department, the L.A. Tarasevich State Institute for Standardization and Control of Medical Immunobiological Preparations (41 Sivtsev Vrazhek, Moscow, 119002) and to the representative office of Valeant Pharmaceuticals Switzerland GmbH.

Use in pediatrics

It is not recommended to prescribe the drug to children under 15 years of age, because there are currently no data from clinical trials of the drug in children.

Effect on ability to drive vehicles and mechanisms

The use of the drug does not affect the ability to work with mechanisms and drive vehicles.

Overdose

There have been no reports of overdose with Solcotrichovac to date.

Drug Interactions

Against the background of the use of immunosuppressants or radiation therapy, the effect of Solcotrichovac may be weakened.

No cases of incompatibility with the simultaneous use of the drug Solcotrichovac with other drugs have been noted.

Pharmaceutical interaction

It is not recommended to mix Solcotrichovac and other drugs for parenteral use (including vaccines) in the same syringe.

Storage Conditions

The drug should be stored in a dry place, out of the reach of children, at a temperature from 15°C (59°F) to 25°C (77°F) (thermal containers).

Shelf Life

Shelf life – 3 years.

Dispensing Status

The drug is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.