Ozurdex 700 micrograms intravitreal implant in applicator

Země: Malajsie

Jazyk: angličtina

Zdroj: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktivní složka:

DEXAMETHASONE; DEXAMETHASONE; DEXAMETHASONE

Dostupné s:

ABBVIE SDN BHD

INN (Mezinárodní Name):

DEXAMETHASONE; DEXAMETHASONE; DEXAMETHASONE

Jednotky v balení:

700µg mcg/mL

Výrobce:

ALLERGAN PHARMACEUTICALS IRELAND

Informace pro uživatele

Not Applicable

Charakteristika produktu

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