Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use

Risk of corneal melting or impending perforation

It is important that the risk of corneal melting or impending perforation, and the need to undergo emergency surgery or another procedure is assessed before starting therapy with OXERVATE as cenegermin should not be used in patients requiring immediate surgery.

Eye reactions

OXERVATE may cause mild to moderate eye discomfort, such as eye pain, to the patient. The patient should be advised to contact the doctor in case of concern or a more severe eye reaction.

Use of corticosteroids or eye drops containing preservatives

Use of ophthalmic topical agents known to inhibit epithelial healing, including corticosteroids or eye drops containing preservatives such as benzalkonium chloride, polyquaternium-1, benzododecinium bromide, cetrimide and other quaternary ammonium derivatives, should be avoided during treatment of neurotrophic keratitis, as they could interfere with corneal healing (see section 4.5).

Eye infections

An eye infection should be treated before use of OXERVATE. Should an eye infection occur, OXERVATE should be suspended until infection resolution (see section 4.2).


Ocular cancer
Cenegermin may theoretically affect ocular cancer, as it is a growth factor. OXERVATE should be used with caution in patients with ocular cancer. It is recommended that these patients continue to be monitored for cancer progression during and after treatment with this medicinal product.

Contact lenses

Patients should be instructed to remove contact lenses before applying OXERVATE and to wait 15 minutes after instillation of the dose before reinsertion, because the presence of a contact lens (either therapeutic or corrective) could theoretically limit the distribution of cenegermin onto the area of the corneal lesion.

Effects on Driving

4.7    Effects on ability to drive and use machines

The treatment has minor influence on the ability to drive and use machines, as it may cause temporary blurred vision or other visual disturbances, which is expected to last a few minutes after instillation. If blurred vision occurs at instillation, the patient must wait until the vision clears before driving or using machines.