Ozurdex

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

dexamethasone

Available from:

AbbVie Deutschland GmbH & Co. KG

ATC code:

S01BA01

INN (International Name):

dexamethasone

Therapeutic group:

Ophthalmologicals, Other ophthalmologicals

Therapeutic area:

Macular Edema; Uveitis

Therapeutic indications:

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).Ozurdex is indicated for the treatment of adult patients with inflammation of the posterior segment of the eye presenting as noninfectious uveitis.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.

Product summary:

Revision: 19

Authorization status:

Authorised

Authorization date:

2010-07-26

Patient Information leaflet

25
B. PACKAGE LEAFLET
26
PACKAGE LEAFLET: INFORMATION FOR THE USER
OZURDEX 700 MICROGRAMS INTRAVITREAL IMPLANT IN APPLICATOR
dexamethasone
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor. See section 4.
WHAT IS IN THIS LEAFLET
1.
What OZURDEX is and what it is used for
2.
What you need to know before you are given OZURDEX
3.
How OZURDEX is used
4.
Possible side effects
5.
How to store OZURDEX
6.
Contents of the pack and other information
1.
WHAT OZURDEX IS AND WHAT IT IS USED FOR
The active substance in OZURDEX is dexamethasone. Dexamethasone
belongs to a group of
medicines called corticosteroids.
OZURDEX is used to treat adult patients with:

Vision loss due to diabetic macular oedema (DME), if you have already
had an operation for
cataract, or if you have not previously responded to, or are not
suitable for, other types of
treatment. Diabetic macular oedema 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.

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.
Swelling of the macula may lead to damage which affects your central
vision which is used for
tasks like reading. OZURDEX works by reducing this swelling of the
macular which helps to
lessen or prevent more damage to the macula.

Inflammation of the back of the eye. This inflammation leads to a
decrease of vision and/or
the presence of floaters in the eye, (black dots or wispy lines that
move across the field of
vision). OZURDEX works by reducing this inflammation.
2.
WHAT YOU NEED TO KNOW BEFORE YO

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
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 the 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 INDICATIONS
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

macular oedema following either Branch Retinal Vein Occlusion (BRVO)
or Central Retinal
Vein Occlusion (CRVO) (see section 5.1)

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 treatment followed
subsequently by a loss in visual acuity and in the physician