OZURDEX

Pays: Israël

Langue: anglais

Source: Ministry of Health

Ingrédients actifs:

DEXAMETHASONE

Disponible depuis:

ABBVIE BIOPHARMACEUTICALS LTD, ISRAEL

Code ATC:

R01AD03

forme pharmaceutique:

IMPLANT IN APPLICATOR

Composition:

DEXAMETHASONE 0.7 MG

Mode d'administration:

INTRAVITREAL

Type d'ordonnance:

Required

Fabriqué par:

ALLERGAN PHARMACEUTICALS IRELAND

Groupe thérapeutique:

DEXAMETHASONE

Domaine thérapeutique:

DEXAMETHASONE

indications thérapeutiques:

Ozurdex is indicated for the treatment of adult patients with:• diabetic macular oedema (DME)• macular oedema following either Branch Retinal Vein Occlusion (BRVO) or Central Retinal Vein Occlusion (CRVO).• inflammation of the posterior segment of the eye presenting as non-infectious uveitis.

Date de l'autorisation:

2016-12-31

Notice patient

Page 1 of 5
OZU APL MAY 23 CL
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) -
1986
This medicine is dispensed with a doctor’s prescription only
OZURDEX
®
INTRAVITREAL IMPLANT IN APPLICATOR
ACTIVE INGREDIENT AND ITS QUANTITY
Each implant contains 700 mcg dexamethasone.
Inactive ingredients and allergens in this medicine - Please read
section 6
‘Additional
information’.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet
contains concise information about this medicine. If you have any
further questions,
consult your doctor or pharmacist.
This medicine has been prescribed to treat your illness/for you. Do
not pass it on to
others.
It may harm them, even if it seems to you that their illness/medical
condition is similar to
yours.
1. WHAT IS THIS MEDICINE INTENDED FOR?
Ozurdex is used to treat adults with:
•
Diabetic macular oedema.
This is experienced as swelling of the light-sensitive layer at the
back of the eye
called the macula. Diabetic macular oedema affects some people with
diabetes.
•
Macular oedema 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 cause damage that affects your central
vision which is
used for tasks like reading. Ozurdex works by reducing this swelling
of the macula
and in this way helps to lessen or prevent more damage to the macula.
•
Inflammation in the back of the eye. This inflammation leads to a
decrease of vision
and/or the appearance of floaters in the eye (black dots or fine lines
that move
across the field of vision). Ozurdex works to reduce this
inflammation.
THERAPEUTIC GROUP - corticosteroids.
2. BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
•
you are sensitive (allergic) to the active ingredient dexamethasone or
to any of the
other ingredients in this medicine (see a full list of ingredients in
section 6
‘Addition

Résumé des caractéristiques du produit

OZU API MAY 23 CL
Page 1 of 14
1.
NAME OF THE MEDICINAL PRODUCT
OZURDEX
®
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:
•
diabetic macular oedema (DME)
•
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’s
opinion may benefit from retreatment
without being exposed to significant risk (see section 5.1).
Patients who experience and retain improved vision should not be
retreated. Patients who experience
deterio