Hyalosan Vaginal Gel with Hyaluronic Acid User Manual

Hyalosan Vaginal Gel with Hyaluronic Acid User Manual

MEDICAL DEVICE – INSTRUCTIONS FOR USE

vaginal gel with hyaluronic acid

Read instructions for use carefully before you start using HYALOSAN vaginal gel.
Keep it, you may need to read it again.

Intended purpose: HYALOSAN vaginal gel with hyaluronic acid is intended to maintain naturally moist and slightly acidic environment of the vaginal mucosa thanks to the content of lactic acid.

It is used to support regeneration and restoration of the natural state of the vaginal mucosa in the case of problems caused by:

• vaginal dryness associated with hormonal changes in all stages of a woman’s life, especially during menopause, after labour, during breast-feeding, after chemotherapy and radiotherapy or gynaecological operations,
• vaginal atrophy manifested by itching, burning, redness or unpleasant feelings during intercourse.

HYALOSAN vaginal gel can be used as a lubricant gel in the case of insufficient moisture during intercourse. The device is intended to be used by a lay person – adult women.

Mode of action: The main intended function of the gel on the vaginal mucosa is not obtained by pharmacological, immunological or metabolic means, but thanks to its physical properties, especially hygroscopicity of hyaluronic acid and pH modifying action
of lactic acid. It helps to rebuild the natural physiological state of the vaginal mucosa, contributes to the restoration of optimum humidity, accelerates the healing process, maintains physiological pH levels and prevents the development of pathogenic flora.

Character and its mechanism of action is purely physical, does not act by pharmacological, immunological or metabolic means.

Indications

• Alleviation from the vaginal dryness.
• Treatment of vaginal atrophy manifested by itching, burning, redness or unpleasant feelings during intercourse.

How to use: Wash your hands thoroughly and check the integrity of protective foil before using. Take the tube out of the protective foil and remove the cap of vaginal applicator. Apply while lying on your back. Insert the applicator into the vagina as deeply as possible and press the tube to push out the entire content. Remove the applicator while constantly pressing the tube to prevent the gel getting back into the tube. Stay lying on your back a few minutes after application so the gel can evenly cover the vaginal mucosa. Wash your hands again.

Dosage: One tube daily for the first ten days, then every second to third day for at least 5 to 6 weeks. As a prevention of problems, Hyalosan vaginal gel with hyaluronic acid is also suitable for long-term use with dosage 1 to 2 tubes per week. Apply preferably before the bedtime or before planned sexual intercourse. Use a panty liner as a protection against mild gel discharge from vagina.

Ingredients: Sodium Hyaluronate (min. 0,05 %), Lactic Acid (min. 0,1 %), Glycerin, Hydroxyethyl cellulose, Sodium Benzoate, Aqua.

Contraindications: Do not use during menstruation or in case of increased vaginal secretion. Known hypersensitivity to any ingredient of the product.

Side-effects: Allergic reaction

Warnings: Vaginal gel is intended for vaginal use only. Consult your doctor during pregnancy and when concomitantly using other vaginal preparations (including vaginal contraception). Do not use if the packaging is damaged. Do not use after the expiry date which is stated on packaging.

Precautions: Any serious adverse event that has occurred in relation to the use of device should be reported to the manufacturer and the national competent authority, and product should not be used again.

Storage: Store at temperatures from +5 °C to +25 °C. Keep out of reach of children.

Disposal of the device: Dispose of empty packaging in the appropriate container for sorted waste (paper, plastic).

Date of issue and number of the latest revision of the instructions for use: 5.4.2023, rev.04

2265

Read the instructions for use|
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Batch number|
Use-by date|
Do not re-use|
Temperature limit|
Do not pollute the environment – dispose of used packaging in appropriate container|
Manufacturer|
Unique device identifier|
Use-by date|

Dr. Müller Pharma s.r.o., U Mostku 182, 503 41 Hradec Králové, Czech Republic, info@muller-pharma.cz, tel.: +420 495 809 111 www.muller-pharma.com

References

• Laboratorní spotřební materiál | Schoeller Pharma Praha
• Dr. Müller Pharma, a prominent Czech producer of medical devices, curative cosmetics and food supplements
• Dr. Müller Pharma, přední český výrobce léčiv, zdravotnických prostředků, kosmetiky a doplňků stravy
• Dr. Müller Pharma, přední český výrobce léčiv, zdravotnických prostředků, kosmetiky a doplňků stravy

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