Colpofix® Vaginal Gel for the prevention and treatment of HPV-related cervical mucosal lesions

Vaginal gel in spray form for the prevention and treatment of HPV-induced lesions of the cervical mucosa

Colpofix® is a vaginal gel in spray form for the prevention and treatment of cervical lesions that can be caused by human papillomaviruses (HPV). The product supports the maintenance and restoration of physiological conditions in the cervicovaginal mucosal transformation zone.

Colpofix® can be used in cases of a positive HPV test result or pre-existing HPV-related changes to the cervix. Its special formulation allows for even distribution of the gel on the cervicovaginal mucosa.

How does Colpofix® work?

Colpofix® has thixotropic properties. This means that the consistency of the product changes during spraying. When sprayed, the gel temporarily transforms into a more liquid form and then returns to its gel structure.

This allows Colpofix® to spread evenly and precisely into the depths of the cervicovaginal mucosal area. After application, the gel adheres well to the mucosa and, due to its special consistency, does not immediately run out.

The formulation supports the physiological conditions of the cervicovaginal mucosal transformation zone, thereby creating favorable conditions for the natural regeneration processes of the mucosa.

Studies have investigated and observed positive effects on HPV clearance, the regression of HPV-related cervical lesions, re-epithelialization, and the vaginal flora with the use of Colpofix®.

Area of application

Colpofix® is used for the prevention and treatment of HPV-induced lesions of the cervical mucosa.

The product can be used particularly in cases of a positive HPV test result or pre-existing changes to the cervix.

The application can usefully bridge the time between a positive HPV test result and the next gynecological check-up appointment. However, it does not replace the scheduled gynecological examinations.

Properties and benefits

• For the prevention and treatment of HPV-induced lesions of the cervix

• Suitable for a positive HPV test result

• Can be used for pre-existing HPV-related changes to the cervix

• Supports the physiological conditions of the cervicovaginal mucosal transformation zone

• Possesses special thixotropic properties

• Allows for even distribution on the cervicovaginal mucosa

• Adheres well to the mucosa after application

• Supports the natural regeneration processes of the mucosa

• Studies observed promotion of HPV clearance

• Studies observed increased regression of cervical lesions

• Supports the regeneration of the uppermost cell layer

• Can contribute to improving the vaginal flora

• Anatomically adapted disposable applicators

• Individually packaged applicators

• Hygienic and precise application

• Easy to use

• Good gel adhesion

• Very good tolerability

Dosage and application

Colpofix® is applied once daily before bedtime.

5 sprays are administered into the vagina per application.

The application is performed for 20 days per month. A break of about 10 days is taken during menstruation.

Treatment should be carried out for a minimum of 3 months.

For the exact duration of treatment and the necessary gynecological check-ups, the recommendations of the treating gynecologist should be followed.

Applicator use

Wash hands thoroughly before and after use.

Remove the applicator from its protective cover and place it on the spray nozzle of the bottle.

Do not shake Colpofix® before use.

Carefully insert the anatomically adapted applicator deep into the vagina. Then administer 5 sprays.

After use, remove and dispose of the applicator. The applicators are intended for single use and should not be reused.

Application is preferably performed immediately before bedtime.

Practical tips

• Wash hands thoroughly before and after use.

• Use a new disposable applicator for each application.

• Only remove the applicator from its protective cover immediately before use.

• Do not shake the product before use.

• Carefully insert the applicator deep into the vagina.

• Use 5 sprays per application.

• Dispose of the used applicator afterward.

• Use a fresh towel daily for the intimate area.

• Prefer breathable cotton underwear.

• Avoid vaginal douches.

• Ensure gentle intimate hygiene.

• Continue to attend recommended gynecological check-ups.

Treatment duration and gynecological check-ups

Treatment with Colpofix® should be for at least 3 months. A positive HPV test result or existing cell changes on the cervix require regular gynecological check-ups.

Colpofix® is not a substitute for medically recommended HPV checks, smears, HPV tests, or further examinations of the cervix.

The further course of action depends in particular on the HPV finding, the cytology result, and, if applicable, further gynecological examinations.

Pregnancy

In cases of confirmed or suspected pregnancy, Colpofix® should only be used after consultation with and according to the instructions of a gynecologist.

To date, there is no evidence of specific problems during use in pregnancy. However, due to insufficient data, use during pregnancy cannot generally be recommended at this time.

Storage

Do not store above 25 °C.

Do not use after the expiration date indicated on the packaging.

Keep out of reach of children.

Safety instructions

Do not swallow.

Keep out of reach of children.

Do not use if there is a known allergy or hypersensitivity to any of the ingredients.

In cases of confirmed or suspected pregnancy, gynecological advice should be sought before use.

The use of Colpofix® does not replace regular gynecological examinations and check-ups in cases of a positive HPV test result or changes to the cervix.

If unusual or persistent symptoms occur, medical advice should be sought.

Side effects and tolerability

Colpofix® is characterized by very good tolerability. Nevertheless, as with topically applied products, intolerance reactions or local irritations may occur in individual cases.

If significant or persistent burning, itching, redness, or other unusual symptoms occur, discontinue use and seek medical advice.

Colpofix® should not be used in cases of known hypersensitivity or allergy to any of the ingredients.

Ingredients

Water, sorbitol, carboxymethyl beta-glucan, cross-linked acrylic polymer (polycarbophil), imidazolidinyl urea, sodium dehydroacetate.