Ikervis Dosage/Direction for Use

Treatment must be initiated by an ophthalmologist or a healthcare professional qualified in ophthalmology.
Posology: TREATMENT OF SEVERE KERATITIS WITH DRY EYE DISEASE: The recommended dose is one drop 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 instill more than one drop in the affected eye(s).
Special populations: 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 ciclosporin 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 ciclosporin 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 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 ciclosporin have not been studied beyond 12 months (see Precautions).
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 ciclosporin in children below 4 years in the treatment of severe vernal keratoconjunctivitis.
Adults: The effect of ciclosporin has not been studied in patients above 18 years of age for severe vernal keratoconjunctivitis (VKC).
Patients with renal or hepatic impairment: The effect of ciclosporin 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 Precautions).
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 Precautions).