Solcovagyn (Solution) Instructions for Use

Marketing Authorization Holder

Meda Pharmaceuticals Switzerland, GmbH (Switzerland)

Manufactured By

Legacy Pharmaceuticals Switzerland, GmbH (Switzerland)

ATC Code

G02CX (Other drugs used in gynecology)

Dosage Form

Solcovagyn

Solution for topical use: bottle 0.5 ml 2 pcs.

Dosage Form, Packaging, and Composition

Solution for topical use transparent, colorless.

Excipients : distilled water.

0.5 ml – colorless glass bottles with a capacity of 2 ml (2) complete with 2 additional rubber stoppers – foam plastic containers (1) – cardboard packs.

Clinical-Pharmacological Group

Drug for the treatment of benign lesions of the cervix

Pharmacotherapeutic Group

Local necrotizing agent

Pharmacological Action

A drug for the local treatment of benign lesions of the superficial tissues of the cervix.

When using the drug, an unequal effect on different types of cervical epithelium is observed. When the drug is applied to the ectopic columnar epithelium (cervical ectopy and transformation zone) and the subepithelial stroma (cervical erosion), their immediate devitalization and fixation in vivo occurs.

On the other hand, the multilayer cellular structures of the squamous epithelium of the vaginal part of the cervix and the vaginal mucosa, which are more resistant to the effects of Solcovagyn, remain practically intact.

Devitalization and fixation of the altered tissue occurs within a few minutes and is accompanied by the appearance of a yellowish-white or gray coloration of the tissue.

This phenomenon cannot be classified as a cauterizing effect of acids in the usual sense, since the devitalized (necrotic) epithelium remains in its place in the initial phase and forms a protective layer, which peels off after a few days due to the spontaneous growth of new squamous epithelial cells underneath it.

Pharmacokinetics

The drug acts only at the site of application. No systemic absorption is observed.

Indications

Benign lesions of the superficial tissues of the cervix

• Cervical ectopy;
• Transformation zone;
• Nabothian cysts (after opening);
• Cervical canal polyps (in the absence of endometrial pathology);
• Postoperative granulomas.

ICD codes

Dosage Regimen

The drug is intended exclusively for topical application in the area of the superficial tissues of the cervix. The procedure should be performed only by a specialist gynecologist (using a colposcope). During the procedure, only the affected area should be treated, avoiding contact of the solution with the skin of the external genitalia and the vaginal epithelium.

The contents of 1 bottle are designed for 2 procedures (i.e., equal to a single therapeutic dose).

Before using the drug, vaginal mucus should be removed with a cotton swab. Then treat the affected area with a 3% solution of acetic acid for a clearer visual determination of the boundaries of the lesion.

Next, the affected area should be treated with Solcovagyn solution using a cotton swab wound on a wooden stick. After 1-2 minutes, repeat the treatment with Solcovagyn solution. As experience shows, such double treatment enhances the therapeutic effect.

Follow-up examinations are carried out according to the scheme: 1st examination – 10 days after the procedure, 2nd examination – 14 days after the 1st examination, 3rd examination – 14 days after the 2nd examination.

In case of an unsatisfactory examination result, it is necessary to conduct a repeated course of treatment (2 procedures) and perform the next follow-up examinations according to the above scheme.

Adverse Reactions

To date, no side effects have been observed with the use of Solcovagyn. The treatment is painless and does not lead to the formation of scars or deformation of the cervical canal.

Contraindications

• Malignant changes of the cervix (suspicion of malignancy);
• Cellular dysplasia;
• Pregnancy;
• Hypersensitivity to the components of the drug.

Use in Pregnancy and Lactation

The drug is contraindicated for use during pregnancy.

Special Precautions

Treatment with Solcovagyn is carried out on an outpatient basis and does not imply any restrictions on taking water procedures and sexual activity.

Avoid getting the drug on clothing, skin, and especially in the eyes. If Solcovagyn solution gets on the skin of the external genitalia or the vaginal epithelium, immediately rinse the area of contact with water.

If Solcovagyn solution gets on the skin or in the eyes, immediately rinse the area of contact with plenty of water and, if possible, with a neutralizing solution, such as a 1% sodium bicarbonate solution.

After the procedure, place the used cotton swab into the bottle to a depth of 1 cm, break the stick, close the bottle with the stopper provided in the package to prevent the remaining solution from getting on surrounding objects, and then discard it in the trash container.

Overdose

Symptoms with excessive use of the drug, burns may occur, which can lead to pathological changes in the cervical epithelium.

Treatment symptomatic.

Drug Interactions

To date, no cases of interaction of Solcovagyn with other drugs have been noted.

Storage Conditions

The drug should be stored at a temperature from 15°C (59°F) to 25°C (77°F) in a place inaccessible to children. Handle with care!

Shelf Life

Shelf life – 3 years.

The formation of a crystalline precipitate is possible, which is a consequence of storing the drug at lower temperatures, for example, during transportation. Short-term heating of the drug (1-2 minutes) at 40°C (104°F) leads to the dissolution of the precipitate.

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.