Posology : מינונים

4.2     Posology and method of administration

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.

Patients with an eye infection should be treated before starting therapy with OXERVATE (see section 4.4).

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:
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.

OXERVATE should only be administered using the associated delivery system (vial adapter and pipettes), according to the instructions presented in section 6.6.
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. If eye ointment, gel or other viscous eye drops are used, they should be administered 15 minutes following OXERVATE treatment (see also section 4.5).

In case of concomitant use with contact lenses, see section 4.4.
For instructions on preparation and handling of the medicinal product before administration, see section 6.6.