- Approval Id
- 4a5311cdaf4dab05
- Drug Name
- EYBELIS OPHTHALMIC SOLUTION 0.002%
- Product Name
- EYBELIS OPHTHALMIC SOLUTION 0.002%
- Approval Number
- SIN16150P
- Approval Date
- 2021-04-07
- Registrant
- SANTEN PHARMACEUTICAL ASIA PTE. LTD.
- Licence Holder
- SANTEN PHARMACEUTICAL ASIA PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- SOLUTION, STERILE
- Dosage
- <p><strong>Posology and method of administration</strong><br>
<u>Posology</u><br>
The recommended dose is one drop in the affected eye(s) once daily in the evening.</p>
<p>If a dose is missed, treatment should be continued with the next dose as planned. The dose should not exceed one drop in the affected eye(s) daily.</p>
<p><em>Paediatric population</em></p>
<p>The safety and efficacy of omidenepag isopropyl in children and adolescents have not yet been established. No data are available.</p>
<p><u>Method of administration</u><br>
For ocular use.</p>
<p>Be careful not to touch the tip of the bottle to the eye directly in order to avoid the contamination of the drug.</p>
<p>If more than one topical ophthalmic product is being used, each one should be administered at least 5 minutes apart.</p>
<p>Benzalkonium chloride may change the colour of the contact lenses. Contact lens wearers should remove the contact lenses before using this product and put them back after 5–10 minutes.</p>
- Route Of Administration
- OPHTHALMIC
- Indication Info
- <p><strong>Therapeutic indications</strong><br>
Reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension</p>
- Contraindications
- <p><strong>Contraindications</strong><br>
Hypersensitivity to the active substance or to any of the excipients listed in ‘Description’ – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
<p>Patients with aphakic eyes or intraocular lens (IOL) inserted eyes (see ‘Undesirable effects’ – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p>Concomitant use with tafluprost (see ‘Interactions’ – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
- Atc Code
- S01EX06
- Atc Item Name
- omidenepag
- Pharma Manufacturer Name
- SANTEN PHARMACEUTICAL ASIA PTE. LTD.
