Posology : מינונים

4.2    Posology and method of administration

Treatment with Cystadrops should be initiated under the supervision of a physician experienced in the management of cystinosis.

Posology

The recommended dose is one drop in each eye, 4 times a day during waking hours. The recommended interval between each instillation is 4 hours. The dose could be decreased progressively (to a minimum total daily dose of 1 drop in each eye) depending on the results of ophthalmic examination (such as, corneal cystine crystal deposits, photophobia).
If the patient misses an instillation, the patient should be told to continue the treatment with the next instillation.
The dose should not exceed 4 drops a day in each eye.
The accumulation of corneal cystine crystals increases if Cystadrops is discontinued. The treatment should not be stopped.

Paediatric population
Cystadrops may be used in paediatric patients from 2 years of age at the same dose as in adults (see section 5.1).
The safety and efficacy of Cystadrops in children aged less than 2 years has not been established. No data are available.


Method of administration

For ocular use.

Before the first admnistration, in order to facilitate the administration, the patient should be told to bring back Cystadrops at room temperature. After first opening, the patient should be told to keep the dropper bottle at room temperature.

To avoid sticky eyes in the morning, the patient should be advised to apply the last drop of the day at least 30 minutes before going to bed.

To prevent contamination of the dropper tip and solution, care must be taken not to touch the eyelids, surrounding areas, or other surfaces with the dropper tip of the dropper bottle.

The patient should be told to discard the dropper bottle after 7 days of use.

In case of concomitant therapy with other topical ocular medicinal products, an interval of ten minutes should be allowed between successive applications. Eye ointments should be administered last.