Posology : מינונים

4.2 Posology and method of administration

Posology
Use in adults, including the elderly

The recommended dose is one drop of SIMBRINZA in the affected eye(s) two times daily.

Missed dose
If a dose is missed, treatment should be continued with the next dose as planned.

Hepatic and/or renal impairment
SIMBRINZA has not been studied in patients with hepatic impairment and caution is therefore recommended in this population (see section 4.4).

SIMBRINZA has not been studied in patients with severe renal impairment (CrCl < 30 mL/min) or in patients with hyperchloraemic acidosis. Since the brinzolamide component of SIMBRINZA and its metabolite are excreted predominantly by the kidney, SIMBRINZA is contraindicated in such patients (see section 4.3).


Paediatric population

The safety and efficacy of SIMBRINZA in children and adolescents aged 2 to 17 years have not been established. No data are available.


SIMBRINZA is contraindicated in neonates and infants aged less than 2 years in the decrease of elevated intraocular pressure (IOP) with open-angle glaucoma or ocular hypertension for whom monotherapy provides insufficient IOP reduction because of safety concerns (see section 4.3).

Method of administration

For ocular use.
Patients should be instructed to shake the bottle well before use.

When nasolacrimal occlusion is used and the eyelids are closed for 2 minutes, systemic absorption is reduced. This may result in a decrease in systemic side effects and an increase in local activity (see section 4.4).

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 bottle. Patients should be instructed to keep the bottle tightly closed when not in use.

SIMBRINZA may be used concomitantly with other topical ophthalmic medicinal products to lower intraocular pressure. If more than one topical ophthalmic medicinal product is being used, the medicinal products must be administered at least 5 minutes apart.