Description

GIAVAL VAGINAL SUPPOSITORIES

 

 

Therapeutic Category

Medical device for vaginal administration. Pharmaceutical form vaginal supposiitories 1O vaginal suppositories of 2.7 grams Medical device, it is not a drug.

 

 

Composition

A vaginal suppository contains: Hyaluronic acid sodium salt (10 mg), Epigallocatechin-3-gallate, Thymus vulgaris leaves and flowers mother tincture. Hamamelis Virginiana leaves mother tincture, Calendula Officinalis flowers glycolic extract. Daucus Carota macerated oil, Peru Balsam, Hexylresorcinol, Semisynthetic glycerides, Talc, Diethylene Glycol Monoethyl ether, Colloidal silica

 

 

Destination of use

Adjuvant in the treatment of acute and chronic vulvovaginitis, cervicitis, cervical erosions of various etiologies, simple or infected, leucorrhoea, vulvar itching and vaginal dryness.

The hyaluronic acid contained in the product gives GIAVAL vaginal suppositories a protective action, creating the

conditions to favor the healing processes, re-epithelialization and restoration of the vaginal physiological pH, thus counteracting the proliferation of pathogenic germs.

 

 

Expected clinical Benefits

The expected clinical benefits can be identified in the resolution or reduction of signs and symptoms of vaginitis at the end of treatment.

The identifying signs of the pathologies are the following:

• Subjective symptoms (burning, pain, itching, vaginal dryness, dyspareunia and dysuria)
• Objective symptoms (leucorrhoea, vulvar erythema, vulvar edema and presence of abrasion/ erosion)

 

 

The reduction or disappearance of this symptomatology is an indication of the effectiveness of the product.

 

 

Medical Device performance characteristics

The medical device, if used as prescribed by the package insert and according to normal intended uses. achieves the intended purpose for its intended use. In particular. if the product is used correctly, the hyaluronic acid contained within, is able to form a protective film and contributes to re-epithelialization, and promotes normal healing processes.

How to use GIAVAL

Insert a vaginal suppository in the evening for 10-15 days, preferably at the end of the menstrual cycle.

After carefully cleansing the hands and intimate areas. carry out the following operations, in the evening before go

 

 

 

 

 

 

to bed:

• \/\/ash your hands and intimate areas;
• take a vaginal suppository from the blister;
• separate the two edges of the blister:
• extract the vaginal suppository from the blister;
• insert it deeply into the vagina in a comfortable position for insertion

 

Contraindications

 

Individual knowing hypersensitivity of the user or of the sexual partner towards the components of the product Do not use during pregnancy and lactation.

Use for long periods must be avoided. Do not exceed the previously described doses.

 

Since compatibility with condoms has not been tested. do not use before sexual intercourse. Do not use in patients under the age of 18.

Do not use in pediatric patients.

 

Do not use during concomitant topical therapies or other therapies with other medical device and other medicinal product in light of the fact that no evidence is been collected regarding concomitant therapies with the medical device or with product which could be related to the metabolism of this medical device

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Contraindications, undesirable side effects and risk related to overdose are not know. Not use the product in different ways indicated in this leaflet._lf something related to prolonged use not in accordance with leaflet appears stop immediately use the medical device and see a doctor

 

 

Warnings

 

The product should only be administered vaginally. Do not use in administration routes other than those indicated. Do not swallow

If the medical device is swallowed, consult a doctor immediately and go to the emergency room. Keep out of the 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 coloring: being a natural derivative, the color may undergo slight variations from lot to lot.

 

 

Storage and Disposal

 

Store the product away from heat sources. at a temperature below 25 ° C After use, do not dispose of the container in the environment.

Blister: PVC + polycoated PE. COD “Other 7” Plastic disposal

 

 

 

 

 

 

Illustrative: Card COD “PAP22”, Paper disposal Box: Cardboard COO “PAP21” Paper disposal

Check the dispositions of your municipality of residence.

 

 

 

Side effects

 

Unknown. In case of irritation or unwanted reactions, stop administering the product and consult your doctor.

 

 

 

Adverse events

 

Unknown, if the correct methods of use and instructions given in the illustrative are observed. Any use outside the normal use described in this leaflet should be avoided.

Any adverse event or serious accident must be reported to the Manufacturer in the contacts below and to the Competent Authority of the member state in which the patient/ user is established.

 

 

Content of the packaging

 

10 vaginal suppositories of 2,7 grams