- Approval Id
- e52c6895003d9a19
- Drug Name
- GLANATEC OPHTHALMIC SOLUTION 0.4% W/V
- Product Name
- GLANATEC OPHTHALMIC SOLUTION 0.4% W/V
- Approval Number
- SIN15886P
- Approval Date
- 2020-02-18
- Registrant
- DKSH SINGAPORE PTE. LTD.
- Licence Holder
- DKSH SINGAPORE PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- SOLUTION, STERILE
- Dosage
- <p><strong>4.2 Posology and method of administration</strong></p>
<p><strong>Posology</strong><br>
<u>Use in adults, including the elderly</u><br>
Instill one drop into the affected eye(s) twice daily.</p>
<p><u>Use in paediatric population</u><br>
Safety in low birth weight infants, newborns, infants, and children has not been established.</p>
<p><strong>Method of Administration</strong></p>
<ol class="decimal-enclosed">
<li>Route of administration: Instillation only.</li>
<li>When dispensing the drug: Instruct patients on the following:
<ol class="decimalparen">
<li>In the instillation, the patient should tilt the head backwards, open the affected eye, instill the drug into the conjunctival sac, close the eyelid for 1 to 5 minutes while compressing the lacrimal part, and open the eye.</li>
<li>Be careful during the instillation to avoid direct contact of the tip of the container with the eye in order to prevent contamination of the drug.</li>
<li>Instill with an interval of at least 5 minutes when using the drug in combination with other ophthalmic solutions.</li>
</ol>
</li>
</ol>
- Route Of Administration
- OPHTHALMIC
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong></p>
<p>GLANATEC is indicated to decrease elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma as adjunctive therapy in patients who are insufficiently responsive to topical beta-blockers or prostaglandin analogues, or as monotherapy in patients who are intolerant or contraindicated to other intraocular pressure lowering medications.</p>
- Contraindications
- <p><strong>4.3 Contraindications</strong></p>
<p>GLANATEC is contraindicated in patients with history of hypersensitivity to any of the components of GLANATEC (see Section 6.1 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
- Atc Code
- pending
- Atc Item Name
- xpending
- Pharma Manufacturer Name
- DKSH SINGAPORE PTE. LTD.
- Company Detail Path
- /organization/dksh-singapore-pte-ltd
