Advisory notice relating to eye injuries in humans and dogs when using Osurnia ear gel for dogs

Notice type: Advisory

Date: 26/04/2018

The HPRA wishes to highlight that the European Medicines Agency (EMA) has published on its website an advisory notice concerning eye injuries to pets or their owners from accidental eye exposure to the veterinary medicine Osurnia ear gel for dogs. Osurnia was granted a marketing authorisation by the EMA under a Community authorisation procedure. According to that notice, caution is advised when applying the medicine.

Product name or type:
OSURNIA ear gel for dogs

Authorisation Number:

Active Substance:
terbinafine, florfenicol & betamethasone acetate

Product Classification:
Otological - corticosteroid and anti-infective in combination

Manufacturer Or Supplier:
Argenta Dundee Limited  

Authorisation Holder:
Elanco Europe Ltd.

Prescription Required:

Target Audience:
Veterinary healthcare professionals, dog owners

Problem Or Issue:

Osurnia is an ear gel for the treatment of ear infections in dogs. Eye exposure in people mostly happened when the dog shook its head during or just after applying the medicine. It is not clear if cases in dogs were also due to accidental contact, although this was confirmed in a few reports.

The injuries in people include 2 cases of corneal ulcer (damage to the clear layer at the front of the eye), as well as reports of eye irritation, conjunctivitis, redness, burning, stinging and itchiness. The eye injuries in dogs included corneal ulcers, squinting, impaired vision, conjunctivitis, redness and swelling around the eye.

Background Information Or Related Documents:
Further information can be found on the EMA website.

Actions To Be Taken:

Information for veterinary healthcare professionals:

  • Before Osurnia is applied to dogs, veterinary healthcare professionals should examine the external ear canal to ensure that the eardrum is not perforated.
  • Veterinarians should advise pet owners to take care when applying the medicine. The dog should be properly restrained during administration of Osurnia and appropriate measures should be taken to avoid accidental eye contact with the product.
  • If accidental ocular exposure occurs the eyes should be flushed thoroughly with water for 10 to 15 minutes.
  • Veterinarians should also advise pet owners to monitor dogs treated with Osurnia and to contact their veterinarian in case of any side effects in particular those affecting the eyes.


Information for animal owners:

  • Osurnia is an ear gel used to treat ear infections in dogs. If it contacts the eyes of people or dogs it can cause damage to them.
  • Care should therefore be taken to prevent Osurnia ear gel from contacting the eyes of people applying the medicine, or of other people nearby. This includes restraining the dog’s head when applying the medicine, to prevent the animal shaking its head and splashing the medicine around.
  • Care should also be taken to prevent Osurnia ear gel from contacting the eyes of the dog being treated.
  • If accidental exposure occurs to the eyes of people or dogs, rinse the eyes thoroughly with water for 10-15 minutes and seek medical care.

Any adverse events occurring following use of Osurnia or any other veterinary medicinal product should be reported to the HPRA via the online reporting form available at or to the marketing authorisation holder of the relevant product(s), at the earliest opportunity.


Further Information:
The EMA will continue to monitor the safety of the medicine and take regulatory action as appropriate.

« Back