Ozurdex

Țară: Noua Zeelandă

Limbă: engleză

Sursă: Medsafe (Medicines Safety Authority)

Ingredient activ:

Dexamethasone 700ug

Disponibil de la:

AbbVie Limited

INN (nume internaţional):

Dexamethasone 700 µg

Dozare:

700 mcg

Forma farmaceutică:

Intraocular implant

Compoziție:

Active: Dexamethasone 700ug Excipient: Polyglactin (poly (D, L-lactide-co-glycolide), 50:50 PLGA acid) Polyglactin

Unități în pachet:

Applicator, pre-filled, single dose, The applicator containing the implant is packaged in a sealed foil pouch, 1 implant

Clasă:

Prescription

Tip de prescriptie medicala:

Prescription

Produs de:

Sanofi Chimie

Indicații terapeutice:

OZURDEX® is indicated for the treatment of macular oedema due to Retinal Vein Occlusion (RVO).

Rezumat produs:

Package - Contents - Shelf Life: Applicator, pre-filled, single dose, The applicator containing the implant is packaged in a sealed foil pouch - 1 implants - 36 months from date of manufacture stored at or below 25°C

Data de autorizare:

2009-03-25

Prospect

OZURDEX
®
(dexamethasone) 700 µg intravitreal implant CMI V4.0 PI v6.0
1
OZURDEX
®
(DEXAMETHASONE) 700 ΜG INTRAVITREAL IMPLANT
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about OZURDEX
®
. It
does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you receiving
OZURDEX
®
against the benefits
they expect it will have for you.
If you have any concerns about
using this medicine, ask your
doctor or pharmacist.
KEEP THIS LEAFLET. You may need
to read it again.
WHAT OZURDEX
® IS USED FOR
OZURDEX
®
is contained within a
small implant injected into the back
of the eye by your doctor using a
specially designed applicator.
OZURDEX
®
is used to treat adult
patients with Diabetic Macular
Oedema (DME), which is a swelling
of the light-sensitive layer at the
back of the eye called the macula.
DME is a condition that affects
some people with diabetes.
OZURDEX
®
is used to treat vision
loss caused by a blockage of veins
in the eye. This blockage leads to a
build up of fluid causing swelling in
the area of the retina (the light-
sensitive layer at the back of the
eye) called the macula. The
swelling may lead to damage to the
macula which affects your central
vision which is used for tasks like
reading.
OZURDEX
®
is also used to treat
adult patients with Uveitis, which is
an inflammation affecting the
choroid (the layer of blood vessels
and connective tissue between the
white of the eye and retina at the
back of the eye). Uveitis is a
chronic disease with a high risk of
permanent vision loss.
The active ingredient in
OZURDEX
®
is dexamethasone.
Dexamethasone belongs to a group
of medicines called corticosteroids.
OZURDEX
®
works by reducing the
swelling which helps to lessen or
prevent more damage to the
macula.
BEFORE YOU USE OZURDEX
®
WHEN YOU MUST NOT USE IT
Do not use OZURDEX
®
if:
i
you have an allergy to
dexamethasone or any

Caracteristicilor produsului

OZURDEX
®
Intraocular implant DS v13 draft 1.0 CCDS v10.0 – clean changes –
19Jun2023
1
DATA SHEET
1. PRODUCT NAME
OZURDEX
®
700 µg implant
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
dexamethasone 700 µg
For full list of excipients, see section 6.1 List of Excipients.
3. PHARMACEUTICAL FORM
Dexamethasone is a white to cream-coloured crystalline powder with not
more than a slight
odour, and is practically insoluble in water and very soluble in
alcohol.
OZURDEX
®
is a biodegradable intravitreal implant containing 700 μg
dexamethasone in the
NOVADUR™ solid polymer drug delivery system. OZURDEX
®
is preloaded into a single-use,
specially designed drug delivery system (DDS) applicator to facilitate
injection of the rod-
shaped implant directly into the vitreous. The polymer drug delivery
system contains
polyglactin [poly (D,L-lactide-coglycolide)] PLGA biodegradable
polymer matrix. OZURDEX
®
is preservative-free.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
OZURDEX

is indicated for the treatment of macular oedema due to retinal vein
occlusion
(RVO).
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 non-infectious uveitis affecting the
posterior
segment of the eye.
4.2 DOSE AND METHOD OF ADMINISTRATION
Single-use intravitreal implant in applicator for intravitreal use
only. Treatment with
OZURDEX
®
for retinal vein occlusion, diabetic macular oedema and uveitis is 700
µg per eye
(entire contents of a single-use OZURDEX
®
device).
Repeat doses should be considered when a patient experiences a
response to treatment
followed subsequently by a loss in visual acuity and in the
physician’s opinion may benefit
from retreatment without being exposed to significant risk. Patients
who experience and retain
improved vision should not be retreated. Patients who experienc