Land: Singapur
Sprache: Englisch
Quelle: HSA (Health Sciences Authority)
Dexamethasone
ABBVIE PTE. LTD.
S01BA01
0.7mg
IMPLANT
Dexamethasone 0.7mg
OPHTHALMIC
Prescription Only
Allergan Pharmaceuticals Ireland
ACTIVE
2011-11-23
1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use OZURDEX ® safely and effectively. See full prescribing information. OZURDEX ® (DEXAMETHASONE INTRAVITREAL IMPLANT) ------------INDICATIONS AND USAGE------------ OZURDEX ® contains a corticosteroid indicated for the treatment of macular edema following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO), for the treatment of non- infectious uveitis affecting the posterior segment of the eye, and for the treatment of patients with visual impairment due to diabetic macular edema (DME) who are pseudophakic or who are considered insufficiently responsive to, or unsuitable for non-corticosteroid therapy. (1) ------------DOSAGE AND ADMINISTRATION------------ • For ophthalmic intravitreal injection only. (2.1) • The intravitreal injection procedure should be carried out under controlled aseptic conditions. Following the intravitreal injection, patients should be monitored for elevation in intraocular pressure and for endophthalmitis. (2.2) ------------ DOSAGE FORMS AND STRENGTHS ------------ • Intravitreal implant containing dexamethasone 0.7 mg in the NOVADUR™ solid polymer drug delivery system. (3) ------------ CONTRAINDICATIONS ------------ • Ocular or periocular infections. (4.1) • Advanced glaucoma. (4.2) • Aphakic eyes with ruptured posterior lens capsule. (4.3) • Eyes with ACIOL, iris or transscleral fixated IOLs and rupture of the posterior lens capsule. (4.4) • Hypersensitivity. (4.5) ------------ WARNINGS AND PRECAUTIONS ------------ • Intravitreal injections have been associated with endophthalmitis, eye inflammation, increased intraocular pressure, retinal detachments, and implant migration into the anterior chamber. Patients should be monitored following the injection. (5.1) • Patients who had a tear in the posterior lens capsule (e.g., due to cataract surgery), or who had an iris opening to the vitreous cavity (e.g., due to iridectomy) are at risk of im Lesen Sie das vollständige Dokument