Qualitative and quantitative composition:

An ovule contains: bismuth subgallate – 100mg, vegetable collagen- 15mg, Thyme extract (Thymus vulgaris)- 10mg, Hydrastis canadensis extract – 10mg, Calendula extract (Calendula officinalis) – 10mg, Turmeric extract (Curcuma longa) – 10mg, hexylresorcinol – 2mg, semisynthetic glycerides, anhydrous lanolin, colloidal silicon dioxide.

Aspectul dispozitivului/ Aspect of the device:

Homogeneous ovules, yellow to deep yellow, without undissolved particles or air bubbles. Each box contains 2 blisters with 5 ovules; the weight of an ovule is 2g.

What it is and what it is used for:

Cerviron is intended for adult women (including those in menopause) who suffer from

• acute and chronic vulvovaginitis of atrophic, aerobic, traumatic and infectious etiology
• cervical erosions
• vaginal bleeding of traumatic origin
• postoperative recovery after gynaecological surgery
• disruption of vaginal pH and normal vaginal flora.

It can also be used as an adjuvant in the treatment of antibiotics and antifungals.

Indications:

Cerviron is a medical device intended for use in the treatment of acute and chronic vulvovaginitis of atrophic, aerobic, traumatic and infectious etiology, of cervical erosions of traumatic or infectious origin and of bleeding caused by them, in the postoperative recovery after gynaecological surgeries, for restoration of pH and normal vaginal flora, as well as an adjuvant in treatment with antibiotics / antifungals.

Cerviron is indicated for the treatment of the following symptoms:

• Leucorrhea
• Vaginal pruritus
• Burns in the vaginal area
• Rash
• Vaginal discharge with an unpleasant odour
• Dysuria
• Dyspaneuria
• Vaginal bleeding caused by erosions of the cervix

Cerviron can be used, in association with a specific medicinal treatment, in the treatment of symptoms of vaginal infections with:

• Gardnerella vaginalis
• Trichomonas vaginalis
• Candida albicans
• Yeast cells and filaments

Contraindications:

Do not use Cerviron in case of hypersensitivity to any of the components of the product.

Pregnancy and breast-feeding

Administration to pregnant women can only be done on the recommendation and under the supervision of a specialist doctor. No precautions need to be taken when used during breast-feeding.

Effects on ability to drive and use machines

None of the components of the product affect the ability to drive or use machines.

Interactions with other products:

nteractions with other products are not known, therefore it is recommended to consult a doctor before using Cerviron ovules together with other medical devices or medicines for vaginal use.

Dosage and administration:

An ovule is administered intravaginally, preferably in the evening, before bedtime or as prescribed. The use of ovules begins on the first day after menstruation. The duration of administration is 10 or 15 days a month or as directed by your doctor. Improvement may occur in the first month of treatment. It can be repeated for several months, until healing or to consolidate and maintain the favourable effects obtained.

Special warnings and precautions for use:

Due to the composition of the product, no precautions are generally required. Sanitize your hands and intimate area well before administering the ovule.

Do not use ovules with damaged alveoli or traces of substance on the outside of the alveolus.

Do not use ovules that are uneven in appearance or that show traces of agglomerated particles.

Do not divide the ovules.

Notify the manufacturer or the competent authorities of any serious incident caused by the use of the medical device Cerviron.

Side effects:

Using topical products for a long time may cause local irritation and sensitization. If side effects occur, stop treatment and contact your doctor or pharmacist.

Any serious incident that occurred in relation to the medical device must be reported to the manufacturer and the competent authority of the Member State where the user and/or patient is established.

Overdose:

No cases of overdose are known. The substances contained are not systemically absorbed, the natural ones are eliminated in maximum 24 hours from the administration.

Expiration, storage and disposal:

Store at 2 – 25 ° C in the original package in order to protect from direct sunlight. The term of validity inscribed on the package refers to the product stored under the conditions provided by the manufacturer. The medical device should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medical devices that you no longer use.

Manufacturer:

Perfect Care Manufacturing SRL, no. 82 Complexului street, 085200 Mihailesti city, Giurgiu county, Romania.