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DICOELLE REPAIR
Description
Medical device for vaginal administration.
Adjuvant in the treatment of acute and chronic vulvovaginitis, cervicitis, cervical erosions of various aetiologies, simple or infected, leucorrhoea, vulvar itching and vaginal dryness. The hyaluronic acid in the product gives DicoElle Repair ovules a protective action, creating conditions to promote healing, re-epithelialisation and restoration of physiological vaginal pH, thus counteracting the proliferation of pathogenic germs.
The expected clinical benefits can be identified as the resolution or reduction of signs and symptoms of vaginitis at the end of treatment. The identifying signs of these pathologies are:
- subjective symptoms (burning, pain, itching, vaginal dryness, dyspareunia and dysuria);
- objective symptoms (leucorrhoea, vulvar erythema, vulvar oedema and presence of abrasion/erosion).
The reduction or disappearance of these symptoms is an indication of the product's effectiveness.
The medical device, if used as prescribed by the leaflet and according to normal intended uses, achieves its intended purpose. In particular, if the product is used correctly, the hyaluronic acid contained within is able to form a protective film and contributes to re-epithelialisation, and promotes normal healing processes.
Instructions for use
Insert one ovule in the evening for 10-15 days, preferably at the end of the menstrual cycle, the evening before going to bed.
After thoroughly cleaning hands and intimate areas, perform the following operations:
1) wash hands and intimate areas;
2) take one ovule from the blister;
3) separate the two flaps of the package;
4) extract the ovule from the blister;
5) insert it deeply into the vagina in a comfortable position for insertion.
Components
One ovule contains: sodium hyaluronate (10 mg), epigallocatechin gallate, thyme tincture (Thymus vulgaris), witch hazel tincture (Hamamelis virginiana), calendula extract (Calendula officinalis), carrot oily macerate (Daucus carota), Peru balsam, hexylresorcinol, semi-synthetic glycerides, talc, diethylene glycol monoethyl ether, colloidal silica.
Warnings
Contraindicated in case of individual hypersensitivity of the user or sexual partner confirmed to the product components. Do not use during pregnancy and breastfeeding. Prolonged use should be avoided. Do not exceed the doses previously described. As compatibility with condoms has not been tested, do not use before sexual intercourse. Do not use in patients under 18 years of age. Do not use in pediatric patients. Do not use during concomitant topical therapies or other therapies with other medical devices and other medicines given that no evidence has been collected regarding concomitant therapies with the medical device or with the product that could be related to the metabolism of this medical device. No contraindications, undesirable side effects and risks related to overdose are known. Do not use the product in ways other than those indicated in this leaflet. If anything related to prolonged use not conforming to the leaflet appears, immediately stop using the medical device and consult a doctor.
The product must be administered exclusively vaginally. Do not use in routes of administration other than those indicated. Do not ingest. If the medical device is ingested, contact a doctor immediately and go to the emergency room. Keep out of reach and sight of children. Do not use the product after the expiry date shown on the package. Do not use the product if the package does not appear intact. The product contains carrot oil for colouring: being a natural derivative, the colour may undergo slight variations from batch to batch.
Storage
Store at temperatures not exceeding 25°C.
Shelf life of unopened packaging: 36 months.
Format
Package containing 10 ovules.
Cod. DIC01V
Medical device for vaginal administration.
Adjuvant in the treatment of acute and chronic vulvovaginitis, cervicitis, cervical erosions of various aetiologies, simple or infected, leucorrhoea, vulvar itching and vaginal dryness. The hyaluronic acid in the product gives DicoElle Repair ovules a protective action, creating conditions to promote healing, re-epithelialisation and restoration of physiological vaginal pH, thus counteracting the proliferation of pathogenic germs.
The expected clinical benefits can be identified as the resolution or reduction of signs and symptoms of vaginitis at the end of treatment. The identifying signs of these pathologies are:
- subjective symptoms (burning, pain, itching, vaginal dryness, dyspareunia and dysuria);
- objective symptoms (leucorrhoea, vulvar erythema, vulvar oedema and presence of abrasion/erosion).
The reduction or disappearance of these symptoms is an indication of the product's effectiveness.
The medical device, if used as prescribed by the leaflet and according to normal intended uses, achieves its intended purpose. In particular, if the product is used correctly, the hyaluronic acid contained within is able to form a protective film and contributes to re-epithelialisation, and promotes normal healing processes.
Instructions for use
Insert one ovule in the evening for 10-15 days, preferably at the end of the menstrual cycle, the evening before going to bed.
After thoroughly cleaning hands and intimate areas, perform the following operations:
1) wash hands and intimate areas;
2) take one ovule from the blister;
3) separate the two flaps of the package;
4) extract the ovule from the blister;
5) insert it deeply into the vagina in a comfortable position for insertion.
Components
One ovule contains: sodium hyaluronate (10 mg), epigallocatechin gallate, thyme tincture (Thymus vulgaris), witch hazel tincture (Hamamelis virginiana), calendula extract (Calendula officinalis), carrot oily macerate (Daucus carota), Peru balsam, hexylresorcinol, semi-synthetic glycerides, talc, diethylene glycol monoethyl ether, colloidal silica.
Warnings
Contraindicated in case of individual hypersensitivity of the user or sexual partner confirmed to the product components. Do not use during pregnancy and breastfeeding. Prolonged use should be avoided. Do not exceed the doses previously described. As compatibility with condoms has not been tested, do not use before sexual intercourse. Do not use in patients under 18 years of age. Do not use in pediatric patients. Do not use during concomitant topical therapies or other therapies with other medical devices and other medicines given that no evidence has been collected regarding concomitant therapies with the medical device or with the product that could be related to the metabolism of this medical device. No contraindications, undesirable side effects and risks related to overdose are known. Do not use the product in ways other than those indicated in this leaflet. If anything related to prolonged use not conforming to the leaflet appears, immediately stop using the medical device and consult a doctor.
The product must be administered exclusively vaginally. Do not use in routes of administration other than those indicated. Do not ingest. If the medical device is ingested, contact a doctor immediately and go to the emergency room. Keep out of reach and sight of children. Do not use the product after the expiry date shown on the package. Do not use the product if the package does not appear intact. The product contains carrot oil for colouring: being a natural derivative, the colour may undergo slight variations from batch to batch.
Storage
Store at temperatures not exceeding 25°C.
Shelf life of unopened packaging: 36 months.
Format
Package containing 10 ovules.
Cod. DIC01V

