Oxervate

Treatment should be initiated and supervised by an ophthalmologist or a healthcare professional qualified in ophthalmology. Posology Adults The recommended dose is one drop of OXERVATE in the conjunctival sac of the affected eye(s), 6 times a day at 2 hourly intervals, starting from the morning and within 12 hours.

Treatment should be continued for eight weeks. 4). If a dose is missed, treatment should be continued as normal, at the next scheduled administration. The missed dose can be administered later, within the 12 hours shelf-life of the daily vial.

Patients should be advised not to instil more than one drop in the affected eye(s) during any administration. Special populations Elderly No dose adjustment is required in patients 65 years of age and older. Hepatic and renal impairment 3 The medicinal product has not been studied in patients with hepatic or renal impairment.

However, no dose adjustment is considered necessary in these populations. Paediatric population The safety and efficacy of this medicinal product in children and adolescents below the age of 18 years have not been established. No data are available.

Method of administration For ocular use only.

Precautions to be taken before administering the medicinal product:

Patients should be instructed to wash their hands before use. 6. An individual pipette should be used per application. If more than one topical ophthalmic product is being used, the eye drops must be administered at least 15 minutes apart, to avoid diluting the other product.

5). In case of concomitant use with contact lenses, see section

6 %). e. population included in clinical trials also on indications other than neurotrophic keratitis). Tabulated list of adverse reactions The following adverse reactions listed below were observed in clinical studies in patients suffering from neurotrophic keratitis, treated with OXERVATE 20 mcg/ml.

Adverse drug reactions are presented below according to MedDRA system organ classification (SOC and Preferred Term Level). They are ranked according to system organ class and classified according to the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), or not known (cannot be estimated from the available data).

System organ class Frequency Adverse reaction Infections and infestations Uncommon Corneal abscess Nervous system disorders Common Headache Eye disorders Very common Eye pain Common Eye inflammation, eyelid pain, foreign body sensation in the eye, lacrimation increased, blepharitis, conjunctival hyperaemia, photophobia, eye irritation, corneal deposits.

Uncommon Corneal neovascularization Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

4. 6. 1. 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. 5). Eye infections An eye infection should be treated before use of OXERVATE.

2). 4 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.

1.