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

Nom de l'organisation

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

SRN

PL-MF-000005402

Statut du fabricant

Actif

7 avertissements enregistrés — faire défiler le panneau pour tout voir.

• 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!

Marché principal en Allemagne ; disponible dans 3 pays au total.

Dénomination commerciale

non renseigné

Code d'UDI-DI

04260018197482

Basic UDI-DI

5904335216zel/dopX4

Numéro de référence/catalogue

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

Entité d'attribution

GS1

Catégorie de risque

Classe IIb

Législation applicable

MDR [Règlement (UE) 2017/745 relatif aux dispositifs médicaux]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

Le Gel vaginal ELANEE (dispositif médical) est un gel de haute qualité qui forme une couche protectrice à la surface de la muqueuse, hydrate la muqueuse vaginale et la protège contre les lésions épithéliales causées par la sécheresse vaginale, lors des rapports sexuels, des examens gynécologiques ou de l‘activité physique. L‘application du gel vaginal améliore l‘élasticité du vagin, maintient et rétablit le pH physiologique du vagin, ce qui contribue à préserver la flore bactérienne normale du vagin et à réduire les odeurs désagréables. Le gel vaginal a un pH acide et aide à restaurer l‘environnement physiologique naturel du vagin, ce qui contribue au maintien du microbiome correct de l‘ensemble du système reproducteur féminin (le microbiome vaginal est l‘ensemble des microorganismes, y compris les bactéries, qui vivent dans l‘hôte et régulent un certain nombre de fonctions physiologiques). Ce dispositif médical (bzw. dispositif médicaux) peut donc être utilisé pour traiter la vaginose bactérienne (VB) et en complément des traitements visant à prévenir et à traiter l‘endométriose.

URL des informations complémentaires

https://www.lideal.pl/

Dimensions cliniques

• 5 MU03

• Numéro de lot
• Date d'expiration
• Date de fabrication
• Numéro de série
• Identification du logiciel

Nomenclature européenne des dispositifs médicaux — la classification produit UE attribuée à ce dispositif.

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