ELANEE Vaginal-Gel 7 applicators DE, EN, FR, IT

Organization name

LABORATOIRE L'IDEAL Parisien Sp. z o.o.

SRN

PL-MF-000005402

Manufacturer status

Active

7 warnings recorded — scroll inside the panel to see all entries.

• CW275

  During pregnancy and breastfeeding, use only after consulting your doctor or pharmacist.
• CW007

  Do not use the product if the applicator is damaged
• CW129

  ● When using the product in patients with severe vaginal dryness, due to the lactic acid content of the product, slight reactions may occur at the site of application (mild burning or itching). These symptoms are temporary and usually disappear spontaneously. If the symptoms persist, this may indicate hypersensitivity to the ingredients of the product. In this case, discontinue use of the product and consult your doctor or pharmacist.
• CW277

  • If vaginal dryness persists, consult your doctor or pharmacist
• CW160

  • Avoid accidental contact of the gel with the mucous membranes of the eyes, nose or mouth.
• CW149

  Store at temperatures between 15 °C and 25 °C in the original packaging.
• CW999

  • Hypersensitivity to the product ingredients / occurrence of adverse reactions after use of the product: ● Do not use the product if you are hypersensitive (allergic) to any of its ingredients. ● If the patient has no known hypersensitivity to the ingredients of the product and during use of the gel a burning sensation, itching or redness appears which does not subside spontaneously, this may indicate hypersensitivity to the ingredients of the product, in which case you should discontinue use of the product and consult your doctor or pharmacist. • Do not use when trying to conceive, as the pH of the gel has an adverse effect on sperm. • Do not use during menstruation. • Do not use with local anaesthetics and other vaginal preparations, including vaginal contraceptive preparations, as the product may weaken their effect. • Do not use the product if the applicator is damaged. • Do not reuse an applicator once it has been opened. • Do not use after the expiry date. • If the entire dose of the product has not been used, the applicator should be disposed of. Do not attempt to reuse an opened product at a later date. This is contrary to the guidelines for use and storage of the product and may carry a risk of infection at the application site due to loss of product stability as a result of improper storage conditions. • Use the product immediately after dispensing the dose from the packaging, i.e. from the tube. The dispensed product cannot be used at a later time. • The tube is a single-use dose; any unused amount should be disposed of in accordance with applicable regulations. • The product is intended for vaginal use only. Do not swallow!

Primary placement in Germany; available across 3 countries total.

Trade name

not provided

UDI-DI code

04260018197482

Basic UDI-DI

5904335216zel/dopX4

Reference / catalog number

ELANEE Vaginal-Gel 7 applicators DE, EN, FR, IT

Issuing entity

GS1

Risk category

Class IIb

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

The ELANEE Vaginal gel (medical device) is a high-quality gel that forms a protective layer on the surface of the mucous membrane, which moisturises and protects the vaginal mucosa from epithelial damage caused by vaginal dryness, during intercourse, gynaecological examinations or physical activity. The use of the vaginal gel improves vaginal elasticity, maintains and restores the physiological pH of the vagina, which helps to maintain the normal bacterial flora in the vagina and reduces unpleasant odours. The vaginal gel has an acidic pH and helps restore the natural, physiological environment of the vagina, which translates into maintaining the proper microbiome of the entire female reproductive system (the vaginal microbiome is the entire set of microorganisms, including bacteria, that live in the host and regulate a number of physiological functions), Therefore, the medical device can be used to treat bacterial vaginosis (BV) and as a supplement to therapies used in the prevention and treatment of endometriosis

Additional information URL

https://www.lideal.pl/

Clinical sizes

• 5 MU03

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• U0803VAGINAL DEVICES IN THE FORM OF SOLUTIONS/CREAMS/OVA/TABLETS