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HSA Approval

ZYLET® STERILE OPHTHALMIC SUSPENSION

SIN13647P

ZYLET® STERILE OPHTHALMIC SUSPENSION

ZYLET® STERILE OPHTHALMIC SUSPENSION

May 4, 2009

BAUSCH & LOMB (SINGAPORE) PRIVATE LIMITED

BAUSCH & LOMB (SINGAPORE) PRIVATE LIMITED

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantBAUSCH & LOMB (SINGAPORE) PRIVATE LIMITED
Licence HolderBAUSCH & LOMB (SINGAPORE) PRIVATE LIMITED

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore Classification

Formulation Information

SUSPENSION, STERILE

**DOSAGE AND ADMINISTRATION:** SHAKE VIGOROUSLY BEFORE USING. Apply one or two drops of Zylet into the conjunctival sac of the affected eye(s) every four to six hours. During the initial 24 to 48 hours, the dosing may be increased, to every one to two hours. Frequency should be decreased gradually as warranted by improvement in clinical signs. Care should be taken not to discontinue therapy prematurely. Not more than 20 mL should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS above – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.

OPHTHALMIC

Medical Information

**INDICATIONS AND USAGE:** Zylet is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists.

**CONTRAINDICATIONS:** Zylet, as with other steroid anti-infective ophthalmic combination drugs, is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. Zylet is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.

S01CA

复方中的皮质甾体激素类药和抗感染药

Manufacturer Information

BAUSCH & LOMB (SINGAPORE) PRIVATE LIMITED

Bausch & Lomb, Incorporated

Active Ingredients

Loteprednol Etabonate Micronized Sterile

5 mg/ ml

Loteprednol etabonate

Tobramycin

3mg/ ml

Tobramycin

Documents

Package Inserts

Zylet Sterile Ophthalmic Suspension PI.pdf

Approved: May 17, 2019

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