10 mL 1. COMPOSITIONEach mL contains: 2. PHARMACEUTICAL FORMSterile Ophthalmic Solution. 3. THERAPEUTIC CLASSOphthalmic Corticosteroid / Fluoroquinolone Antibacterial Combination. 4. INDICATIONSTreatment of steroid-responsive ocular inflammation when concomitant antibacterial therapy is appropriate. Management of ocular inflammation associated with susceptible bacterial infection or risk of bacterial infection. May be used for postoperative ocular inflammation when prescribed by an ophthalmologist.
5. CONTRAINDICATIONSHypersensitivity to Betamethasone, Ofloxacin, other quinolones, or any component of the formulation. Herpes simplex and other viral infections of the cornea or conjunctiva. Fungal or mycobacterial ocular infections. Untreated purulent ocular infections. For topical ophthalmic use only.
6. DRUG INTERACTIONSNo significant systemic drug interactions are expected with topical ophthalmic administration.
If other ophthalmic preparations are being used, allow an interval of at least 5–10 minutes between applications. 7. ADMINISTRATIONInstill 1–2 drops into the affected eye(s) 3–4 times daily, or as directed by an ophthalmologist. Wash hands before use. Do not touch the dropper tip to the eye, eyelids or other surfaces. Use only for the prescribed duration. Prolonged corticosteroid use may increase intraocular pressure and the risk of secondary ocular infection. Remove contact lenses before application and reinsert as directed by the physician.
8. STORAGEStore below 25°C, protected from excessive heat and light.
Keep the container tightly closed when not in use.
Keep out of reach of children.
Do not use after the expiry date.
Market : international export Private Label : Avilable Registration Support : Available Regulatory documents : Available on request | 