Descriptive sheet BIPHASIL
Description
Medical device.
An innovative preparation in terms of formulation and method of use. This is a ready-to-use, two-phase wash, consisting of two well-separated solutions that are released into the vagina by simply squeezing the bottle. The blue, water-based phase with cleansing properties is released first, followed by the transparent, oil-gel phase. Thanks to the bioadhesion process, the preparation's active ingredients are evenly and effectively distributed across the mucosa. A protective film forms on the vaginal mucosa, maintaining and possibly facilitating the restoration of the physiological conditions of the vaginal mucosa in the event of inflammatory processes and various types of infections.
For intimate hygiene at the end of the menstrual cycle; as a symptomatic treatment for acute vaginal itching and burning; for heavy vaginal discharge; and as an adjuvant in the treatment of symptoms of various vaginal infections. It also promotes cellular trophism and the restoration of normal physiological conditions in women suffering from vaginal atrophy and dryness.
How to use
1. Do not shake the product before use.
2. Hold the bottle by the ring and press the cannula protection cap with your finger until the safety seal breaks.
3. Remove the cannula from the bottle until it stops, that is, until you hear a small click, and tilt it at approximately 45°.
Only if the cannula is removed correctly will the liquid flow out of the dispenser at the time of administration.
If this does not happen, pull the cannula out further until you hear a click.
4. Turn the bottle upside down with the cannula facing downwards so that the two Biphasil solutions are arranged with the blue phase corresponding to the cannula and the transparent phase towards the top of the bottle.
5. Gently insert the cannula deep into the vaginal canal.
6. Squeeze the bottle until it is completely empty, keeping it in a vertical position, so that first the blue solution and then the clear solution flow into the vagina.
Apply once daily or as directed by your doctor.
Components
Water, liquid paraffin, cross-linked acrylic polymer (polycarbophyl), fat-soluble hyaluronic acid sodium salt, sodium dehydroacetate, sodium coco-amphoacetate, vitamin E acetate, phenoxyethanol, ethylhexylglycerin, CI 42090.
Warnings
The product is for vaginal use. Do not ingest. Do not use in case of hypersensitivity or incompatibility to any component of the product. In case of confirmed or suspected pregnancy and in case of concomitant local pharmacological therapies, the gynecological solution should be used only on the advice of your doctor or pharmacist. The product is not intended for pediatric use. Keep the product out of the sight and reach of children. Prolonged use of the product, as with all topical products, may cause sensitization or local irritation. If this occurs, discontinue use and consult your doctor or pharmacist. Do not use the product if the packaging or cannula is damaged or not perfectly intact when first opened. Use the product according to the instructions for use. The container should be used immediately after opening. Any residue should not be reused. Do not use the product after the expiration date indicated on the packaging.
Conservation
Store in a dry place, away from light and heat sources, at a controlled temperature below 30°C.
Shelf life in intact packaging: 36 months.
Format
4 single-use 150 ml bottles.