ISIDE HPV® is a medical device CE 0425 – Class IIa.
PRODUCT DESCRIPTION
Iside HPV® is a medical device in vaginal ovules indicated for prevention and adjuvant treatment of HPV-induced lesions (HPV, Human Papilloma Virus). Iside HPV forms a protective barrier on the trasformation zone of the cervix to prevent the risk of HPV integration. Thanks to its restorative action, it improves the healing process of HPV-induced lesions.
The pack contains 14 ovules for vaginal use.
INGREDIENTS
A vaginal ovule contains: Hyaluronic acid sodium salt, Lactic acid, Citric Acid, Arabinogalactan, Zinc citrate, Glycerol, Limnanthes Alba (Meadowfoam) Seed Oil, Butyrospermum Parkii (Shea Butter) Extract, Polyethylene glycol 1500, Polyethylene glycol 300.
PRODUCT SPECIFICATION
HOW TO USE
Insert an ovule deeply into the vagina, in the evening before going to bed and lying on your back. It is recommended applying one ovule per day. Do not exceed the recommended dose.
WARNINGS
The product is for vaginal use. Do not swallow. Do not use in case of hypersensitivity and incompatibility with any component of the product. In case of presumed or confirmed pregnancy and in case of concomitant local pharmacological therapies, given the absence of specific studies and data, the use of vaginal ovules must only take place behind the advice of your doctor. The product is not intended for pediatric use. Keep out of sight and reach of children. Prolonged use of the product, as for all topical products, can give rise to sensitization or local irritation, if this happens, stop treatment and consult your doctor. Not use the product if the packaging, when first opened, is damaged or not perfectly intact. Do not use the product after the expiry date indicated on the package. Single use device, the reuse could compromise the safety of the device.
The Human Papilloma Virus (HPV) belongs to the Papovaviridae family and is a DNA epitheliotropic virus, whose replication occurs in the cells of the epidermis. Over 150 types of HPV have been identified of which at least 35 types primarily infect the genital tract. Among these, HPV 16 and 18 turned out to be the main responsible of the tumor evolution of the infection. The natural history of HPV infection is strongly conditioned by the balance that is established between the host and the infecting agent. Generally, the virus replicates by exploiting the cells of the skin and mucous membranes and promoting an excessive growth (hyperplasia) which causes the typical formations: warts, condylomas and papillomas of the skin and mucous membranes. Some types of HPV, the so-called risk genomes, can cause dysplastic lesions such as: low grade squamous intraepithelial lesion (LSIL), high grade squamous intraepithelial lesion (HSIL), squamous cell carcinoma, atypical glandular cells (AGC), endocervical adenocarcinoma in situ (AIS) and adenocarcinoma. HPV infection is contracted directly and mainly sexually. The risk factors considered most relevant are young age, the number of sexual partners and the frequency of intercourse. Clinical diagnosis of HPV infection is made by the doctor who detects the presence of the typical lesions. The diagnosis of cytological and/or histological alterations caused by potentially oncogenic HPV strains is instead obtained through the execution of the Pap Test or specific tests for the detection of viral DNA (HPV-test). If necessary, targeted biopsies of the genital mucosa are carried out, under the control of a particular instrument (the colposcope) which allows the enlarged view of the tissues examined.
HYALURONIC ACID (HA) is a macromolecule naturally produced by our body and represents the main constituent of the connective tissue, where it guarantees hydration, turgidity, viscosity and plasticity.
Iside HPV® contains PrincipHYAL®, sodium hyaluronate obtained with a biotechnology starting from an enzymatic fermentation process, in which the modulation of parameters of pressure, temperature and time allows to obtain HA chains with a broad spectrum of molecular weight, rather than chains with a single molecular weight peak.
Thanks to its ability to bind molecule of water, HA creates an invisible film that improves the elasticity of the vaginal mucosa.
LACTIC ACID and CITRIC ACID are two acidifying agents that lower the vaginal pH by restoring the physiological acidity of the vaginal microenvironment.
ARABINOGALACTAN is a polysaccharide consisting mainly of galactose and arabinose, with varying amounts of uronic acids. Natural fiber known for a prebiotic effect: it represents a nourishment for the “good bacteria”, favoring the growth and proliferation of lactobacilli. In this way arabinogalactan helps to restore vaginal eubiosis.
Anything that suppresses the immune defenses can lead to the appearance of an HPV infection or a worsening of the degree of the lesions. A healthy lifestyle is therefore of fundamental importance. Quitting smoking, exercising, avoiding drugs and alcohol, limiting stress, eating healthily, having safe sex can interfere with the evolution of the disease. The number of sexual partners had in life and the number of partners had by one’s partner increase the risk of developing cervical cancer. The condom does not protect 100% but limits the possibility of exposing oneself to infection (not only of the papillomavirus, but also of all sexually transmitted diseases, obviously including the AIDS virus). The surest way to prevent any tumors associated with the presence of papillomavirus in predisposed subjects is to perform regular Pap test and colposcopy (with deadlines depending on the type of lesion diagnosed). Therefore, always implement correct annual prevention and in case of positivity, promptly contact your trusted gynecologist to undertake a path of serious checks and correct therapies.
