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HSA Approval

LATANO SANTEN OPHTHALMIC SOLUTION, 0.005%w/v

SIN16849P

LATANO SANTEN OPHTHALMIC SOLUTION, 0.005%w/v

LATANO SANTEN OPHTHALMIC SOLUTION, 0.005%w/v

August 31, 2023

SANTEN PHARMACEUTICAL ASIA PTE. LTD.

SANTEN PHARMACEUTICAL ASIA PTE. LTD.

Regulatory Information

SANTEN PHARMACEUTICAL ASIA PTE. LTD.

SANTEN PHARMACEUTICAL ASIA PTE. LTD.

Therapeutic

Prescription Only

Formulation Information

SOLUTION, STERILE

**\[DOSAGE AND ADMINISTRATION\]** Instill one drop in the affected eye(s) once daily. Optimal effect is obtained if latanoprost is administered in the evening. The dosage of latanoprost should not exceed once daily since it has been shown that more frequent administration decreases the IOP lowering effect. If one dose is missed, treatment should continue with the next dose as normal. Latanoprost may be used concomitantly with other classes of topical ophthalmic drug products to lower IOP. If more than one topical ophthalmic drug is being used, the drugs should be administered at least five minutes apart. Contact lenses should be removed before instillation of the eye drops and may be reinserted after fifteen minutes Paediatric population Latanoprost eye drops may be used in paediatric patients at the same posology as in adults. No data are available for preterm infants (less than 36 weeks gestational age). Data in the age group <1 year (4 patients) are limited (see section **Precautions for Use** – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).

OPHTHALMIC

Medical Information

**\[INDICATIONS\]** Reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma and ocular hypertension. It may also be used for the reduction of elevated intraocular pressure as an adjunct medical therapy in patients with primary chronic angle closure glaucoma. Reduction of elevated intraocular pressure in paediatric patients with elevated intraocular pressure and paediatric glaucoma.

**\[CONTRAINDICATION\]** Known hypersensitivity to latanoprost or any other component of the product.

S01EE01

latanoprost

Manufacturer Information

SANTEN PHARMACEUTICAL ASIA PTE. LTD.

Santen Pharmaceutical Co., Ltd. Noto Plant

Active Ingredients

Latanoprost

0.005%w/v

Latanoprost

Documents

Package Inserts

Latano Santen PI.pdf

Approved: August 31, 2023

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