VERKAZIA Eye drops, emulsion Ref.[27520] Active ingredients: Ciclosporin

Verkazia treatment must be initiated by an ophthalmologist or a healthcare professional qualified in ophthalmology.

Posology

Children from 4 years of age and adolescents

The recommended dose is one drop of Verkazia 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 Verkazia have not been studied beyond 12 months. (see section 4.4).

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 Verkazia in children below 4 years in the treatment of severe vernal keratoconjunctivitis.

Adults

The effect of Verkazia has not been studied in patients above 18 years of age.

Patients with renal or hepatic impairment

The effect of Verkazia 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).

If more than one topical ophthalmic medicinal product is being used, the medicinal products must be administered at least 15 minutes apart. Verkazia should be administered last (see section 4.4).

A topical overdose is not likely to occur after ocular administration. If overdose with Verkazia occurs, treatment should be symptomatic and supportive.

3 years.

Do not freeze.

Store below 30°C.

Keep single-dose containers in the pouch in order to protect from light and avoid evaporation.

Discard the opened single-dose container immediately after use.

0.3 mL single-dose, low-density polyethylene (LDPE) containers in a sealed laminate aluminium pouch.

One pouch contains 5 single-dose containers.

Pack sizes of 30, 60, 90 or 120 single-dose containers.

Not all pack sizes may be marketed.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.