OZURDEX IMPLANT

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Abbvie (Pty) Ltd

Dosage:

See ingredients

Pharmaceutical form:

IMPLANT

Composition:

EACH INTRAVITREAL IMPLANT CONTAINS DEXAMETHASONE 700,0 ug

Authorization status:

Registered

Authorization date:

2012-07-12

Patient Information leaflet

AbbVie (Pty) Ltd
OZURDEX
Dexamethasone 700 μg per implant
Intravitreal implant
1.3.2 Patient Information Leaflet
DATE OF LAST AMENDMENT
01 December 2021
DATE OF THIS AMENDMENT
DATE OF LAST APPROVAL
10 May 2022
AMENDMENT TYPE
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS:
OZURDEX, 700 ΜG INTRAVITREAL IMPLANT
DEXAMETHASONE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN OZURDEX
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, pharmacist,
nurse or other health
care provider.
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 to receive OZURDEX
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 a small implant given by injection under local anaesthetic
into the back of the
eye by your eye doctor. OZURDEX is supplied in a pack with the implant
already inside a
specially-designed applicator which will be used once and then thrown
away.
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 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.
S4
AbbVie (Pty) Ltd
OZURDEX
Dexamethasone 700 μg per implant
Intravitreal implant
1.3.2 Patient Information Leaflet
DATE OF LAST AMENDMENT
01 December 2021
DATE OF THIS AMENDMENT
DATE OF LAST APPROVAL
10 May 2022
AMENDMENT TYPE
•
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) c

Summary of Product characteristics

AbbVie (Pty) Ltd
OZURDEX
Dexamethasone 700 μg per implant
Intravitreal implant
1.3.1.1 Professional Information
Page 1 of 23
DATE OF LAST AMENDMENT
01 December 2021
DATE OF THIS AMENDMENT
DATE OF LAST APPROVAL
10 May 2022
AMENDMENT TYPE
SCHEDULING STATUS
1.
NAME OF THE MEDICINE
OZURDEX 700 micrograms intravitreal implant
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.
White to off-white rod-shaped implant containing dexamethasone located
in the needle of a
disposable applicator.
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);
•
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.
S4
AbbVie (Pty) Ltd
OZURDEX
Dexamethasone 700 μg per implant
Intravitreal implant
1.3.1.1 Professional Information
Page 2 of 23
DATE OF LAST AMENDMENT
01 December 2021
DATE OF THIS AMENDMENT
DATE OF LAST APPROVAL
10 May 2022
AMENDMENT TYPE
_DME _
Patients treated with OZURDEX who have experienced an initial response
and who in the
ophthalmologist’s opinion may benefit from retreatment without being
exposed to significant
risk may be considered for retreatment.
Retreatment may be performed after approximately 6 months if the
patient experiences
decreased vision and/or an increase in re