Instructions manual2017-11-29T14:02:56+00:00

Instructions of use for Gynorm 0,5%

Vaginal Gel based on Hyaluronic Acid

QUALITATIVE COMPOSITION

Sodium hyaluronate, 25 mg (0.5%).

High molecular weight > 2,000,000 Daltons

Lactic acid, 11,5 mg.

Excipients: water for injection, lactate buffer.

PRODUCT CLASSIFICATION

Medical device – not sterile – class I.

PACKAGE

Pre-filled disposable plastic containers which contain 5ml of hyaluronic acid (0.5%).

Each package contains seven plastic containers with 5ml of vaginal gel, which diminishes the possibility of mistaken use and increases the patient’s adherence to treatment.

INDICATIONS

GYNORM  is intended for:

  • atrophic and dystrophic states of the vagina and senile dryness owing to estrogen deficiency
  • for vaginal dryness and its symptoms, such as itching, burning sensation, dyspareunia (painful sexual intercourse)
  • for cases of vaginal dryness and associated symptoms due to frequent enema, syringe procedures and gastric disorders
  • when taking antibiotics, antimycotics, hormones, contraceptives, etc.
  • for vaginal dryness after delivery (especially after cesarean delivery) and during lactation
  • after gynecological surgery (such as ovarian removal)
  • when applying antiestrogen therapies, chemotherapy or radiotherapy
  • after menstruation
  • preventively, in the context of a healthy lifestyle, 5ml once a week and one single use after the end of the menstrual period to prevent infections and vaginal dryness, as well as the symptoms that accompany it.

ADVERSE REACTIONS AND SIDE EFFECTS

If vaginal irritation occurs, discontinue administration and seek medical advice.

Individual intolerability to ingredients present in the gel.

WARNINGS AND SPECIAL PRECAUTIONS FOR USE

  • Do not use if the solution is not transparent and colorless.
  • Do not use if the package is opened or damaged.
  • The product must be used immediately after opening.
  • The product is intended for single use. Do not reuse. After use, the unused product must be disposed of. Do not use product residuals. Once the product has been used for the first time, any residuals from the product are not suitable for repeated use.
  • Do not freeze.
  • The product must not be administered orally.
  • During use of GYNORM, external vaginal care can be maintained using clean water without soap.
  • During pregnancy and breastfeeding, consult your doctor before use.

HOW TO USE

  • Check package integrity before use.
  • Check the expiry date indicated on the product. Do not use after the expiry date.
  • Take one of the plastic containers with GYNORM Vaginal Gel.
  • Rotate seal counterclockwise and remove it.
  • Get in supine or laying position and introduce the cannula into vagina as deep as possible.
  • Squeeze the contents into vagina. Small residue of gel in the polymer container must be disposed of after use.Allow exposition of GYNORM for at least 8 hours.

DOSAGE

Recommended dosage with dryness of vaginal mucosa is 5ml, 1-2 times a day, until symptoms are relieved. If the symptoms return, repeat the treatment, but do not use treatment for longer than 20-30 days. Longer use is possible only with a doctor’s medical prescription.

SHELF LIFE

Two years in an intact package.

HOW TO STORE

Store at temperatures from 5 °C up to 25 °C, away from direct light and heat, in properly sealed packaging.

The expiry date is applicable to the product when correctly stored in an intact package.

DISPOSAL

The product must be disposed of in accordance with applicable laws on medical waste.

gynorm-tabl1

Diaco Biofarmaceutici S.R.L.

Via Flavia 124, 34147 Trieste- Italy