IKERVIS EYE DROPS, EMULSION 1MG/ML

EMULSION

**4.2 Posology and method of administration** IKERVIS treatment must be initiated by an ophthalmologist or a healthcare professional qualified in ophthalmology. Posology _Treatment of severe keratitis in dry eye disease_ _Adults_ The recommended dose is one drop of IKERVIS once daily to be applied to the affected eye(s) at bedtime. Response to treatment should be reassessed at least every 6 months. If a dose is missed, treatment should be continued on the next day as normal. Patients should be advised not to instil more than one drop in the affected eye(s). _Elderly patients_ The elderly population has been studied in clinical studies. No dose adjustment is required. _Patients with renal or hepatic impairment_ The effect of IKERVIS has not been studied in patients with hepatic or renal impairment. However, no special considerations are needed in these populations. _Paediatric population_ There is no relevant use of IKERVIS in children and adolescents aged below 18 in the treatment of severe keratitis in patients with dry eye disease, which has not improved despite treatment with tear substitutes. _Treatment of severe VKC_ _Children from 4 years of age and adolescents_ The recommended dose is one drop of IKERVIS 4 times a day (morning, noon, afternoon and evening) to be applied to each affected eye during the VKC season. If signs and symptoms of VKC persist after the end of the season, the treatment can be maintained at the recommended dose or decreased to one drop twice daily once adequate control of signs and symptoms is achieved. Treatment should be discontinued after signs and symptoms are resolved, and reinitiated upon their recurrence. Efficacy and safety of IKERVIS in VKC has not been studied beyond 12 months. (see section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). If a dose is missed, treatment should be continued on the next instillation as normal. Patients should be advised not to instill more than one drop for each instillation in the affected eye(s). _Children below 4 years_ There is no relevant use of IKERVIS in the treatment of VKC in children below 4 years. _Adults_ The effect of IKERVIS in VKC has not been studied in patients above 18 years of age. _Patients with renal or hepatic impairment_ The effect of IKERVIS in VKC has not been studied in patients with renal or hepatic impairment. However, no special dose adjustment is needed in these populations. Method of administration Ocular use. _Precautions to be taken before administering the medicinal product_ Patients should be instructed to first wash their hands. Prior to administration, the single-dose container should be gently shaken. For single use only. Each single-dose container is sufficient to treat both eyes. Any unused emulsion should be discarded immediately. Patients should be instructed to use nasolacrimal occlusion and to close the eyelids for 2 minutes after instillation, to reduce the systemic absorption. This may result in a decrease in systemic undesirable effects and an increase in local activity (see section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). If more than one topical ophthalmic medicinal product is being used, the medicinal products must be administered at least 15 minutes apart. IKERVIS should be administered last (see section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).