Artelac Otic

Dénomination commerciale

Artelac Otic

05905718013210

5902020885058X

Numéro de référence/catalogue

N/A

GS1

Classe III

Législation applicable

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

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

Капките за уши AURIDOL са медицинско изделие, чието действие се основава на осмотичните свойства на глицерола. Основната съставка на капките AURIDOL е глицерол. Глицеролът притежава две основни свойства, които са от значение за употребата му в капки за уши: маслената му консистенция, благодарение на която той нежно прилепва към кожата на мястото на приложение и осигурява защитните си свойства, както и хигроскопичността му, благодарение на която локално приложеният глицерол извлича вода от оточните тъкани (осмотичен ефект). В резултат на това отокът намалява, а вследствие на това намалява и интензивността на болката.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

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

• M9002PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)

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

• Ne pas utiliser si l’emballage est endommagé

  If the packaging has been damaged.

• If the ear drum is damaged (e.g. chronic otitis media); • medical device should only be used after a thorough otoscopic examination by a doctor; • the expiry date printed on the packaging has expired; • the patient is immediately after surgery or surgical treatment in the ear; • in children under 6 months of age; • in case of prolonged pain or swelling caused by inflammatory condition with bacterial or fungal basis, these ailments require contact with a doctor; • in case of ear discharge - leakage from the ear; • medical device should not be applied to the ear with the hearing aid fitted, medical device should be applied one hour before the hearing aid is ingested into the outer ear canal; • although there is no evidence that medical device drops have a negative effect when used during pregnancy and breast-feeding, the use of medical device drops should be consulted with a doctor who should assess whether the expected benefits of it exceed the potential risk; • if symptoms intensify or there is no improvement after three days of using medical device ear drops or if you have a fever, contact your doctor. Prolonged pain or swelling may signal a bacterial or fungal infection that may require further and more appropriate treatment; • for external use only; • avoid contact with eyes, mouth and throat and nose mucous membranes; • It is intended for temporary relief of ear pain, no longer than 3 days and should not be used chronically.

  AUTRE

• EUH 208 - Contient <nom de la substance sensibilisante>. Peut produire une réaction allergique.

  An allergy to any of the components of the product has been previously detected; (Glycerol and lidokaine).