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HSA Approval

XALATAN EYE DROPS 0.005%

SIN09549P

XALATAN EYE DROPS 0.005%

XALATAN EYE DROPS 0.005%

November 21, 1997

VIATRIS PRIVATE LIMITED

VIATRIS PRIVATE LIMITED

Regulatory Information

VIATRIS PRIVATE LIMITED

VIATRIS PRIVATE LIMITED

Therapeutic

Prescription Only

Formulation Information

SOLUTION

**4.2 Posology and method of administration** Use in adults (including the elderly) 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 (see section **4.4** – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Paediatric population Xalatan 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 **5.1** – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).

OPHTHALMIC

Medical Information

**4.1 Therapeutic 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.

**4.3 Contraindications** Known hypersensitivity to latanoprost or any other component of the product.

S01EE01

latanoprost

Manufacturer Information

VIATRIS PRIVATE LIMITED

PFIZER MANUFACTURING BELGIUM NV

Active Ingredients

LATANOPROST

50 mcg/ml

Latanoprost

Documents

Package Inserts

Xalatan Eye Drops PI.pdf

Approved: June 2, 2022

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