Doloceril

Trade name

Doloceril

05905718013357

5902020885058X

Reference / catalog number

N/A

GS1

Class III

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

As gotas auriculares AURIDOL são um dispositivo médico, cuja ação se baseia nas propriedades osmóticas do glicerol. O principal componente das gotas AURIDOL é o glicerol. O glicerol apresenta duas características fundamentais relevantes para a sua utilização em gotas auriculares: a sua consistência oleosa, que permite uma aderência suave à pele no local de aplicação e é responsável pelas suas propriedades protetoras, e a sua higroscopicidade, que faz com que o glicerol aplicado localmente remova a água dos tecidos edemaciados (efeito osmótico). Como resultado, o edema diminui e, consequentemente, a intensidade da dor é reduzida.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

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

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

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

• Do not use if package is damaged

  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.

  OTHER

• EUH 208 – Contains (name of sensitising substance). May produce an allergic reaction.

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