Ozurdex Intravitreal Implant 0.7mg

Země: Singapur

Jazyk: angličtina

Zdroj: HSA (Health Sciences Authority)

Aktivní složka:

Dexamethasone

Dostupné s:

ABBVIE PTE. LTD.

ATC kód:

S01BA01

Dávkování:

0.7mg

Léková forma:

IMPLANT

Složení:

Dexamethasone 0.7mg

Podání:

OPHTHALMIC

Druh předpisu:

Prescription Only

Výrobce:

Allergan Pharmaceuticals Ireland

Stav Autorizace:

ACTIVE

Datum autorizace:

2011-11-23

Charakteristika produktu

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