Maa: Malesia
Kieli: englanti
Lähde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DEXAMETHASONE; DEXAMETHASONE; DEXAMETHASONE
ABBVIE SDN BHD
DEXAMETHASONE; DEXAMETHASONE; DEXAMETHASONE
700µg mcg/mL
ALLERGAN PHARMACEUTICALS IRELAND
Not Applicable Lue koko asiakirja
1. NAME OF THE MEDICINAL PRODUCT OZURDEX ® 700 micrograms intravitreal implant in applicator 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One implant contains 700 micrograms of dexamethasone. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Intravitreal implant in applicator. Disposable injection device, containing a rod-shaped implant, which is not visible. The implant is approximately 0.46 mm in diameter and 6 mm in length. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATION OZURDEX ® is indicated for the treatment of adult patients with visual impairment due to diabetic macular oedema (DME) who are pseudophakic or who are considered insufficiently responsive to, or unsuitable for non-corticosteroid therapy. OZURDEX ® is indicated for the treatment of adult patients with macular oedema following either Branch Retinal Vein Occlusion (BRVO) or Central Retinal Vein Occlusion (CRVO) (see section 5.1). OZURDEX ® is indicated for the treatment of adult patients with inflammation of the posterior segment of the eye presenting as non-infectious uveitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION OZURDEX® must be administered by a qualified ophthalmologist experienced in intravitreal injections. Posology The recommended dose is one OZURDEX ® implant to be administered intra-vitreally to the affected eye. Administration to both eyes concurrently is not recommended (see section 4.4). DME Patients treated with OZURDEX ® who have experienced an initial response and in the physician’s opinion may benefit from retreatment without being exposed to significant risk should be considered for retreatment. Retreatment may be performed after approximately 6 months if the patient experiences decreased vision and/or an increase in retinal thickness, secondary to recurrent or worsening diabetic macular oedema. There is currently no experience of the efficacy or safety of repeat administrations in DME beyond 7 implants. RVO and Uveitis Repeat doses should be considered when a patient experiences a response to Lue koko asiakirja