OZURDEX

Main information

  • Trade name:
  • OZURDEX dexamethasone 700 microgram intravitreal implant
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • OZURDEX dexamethasone 700 microgram intravitreal implant
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222392
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222392

OZURDEX dexamethasone 700 microgram Intravitreal implant

ARTG entry for

Medicine Registered

Sponsor

Allergan Australia Pty Ltd

Postal Address

Locked Bag 1514,PYMBLE, NSW, 2073

Australia

ARTG Start Date

4/06/2015

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. OZURDEX dexamethasone 700 microgram intravitreal implant

Product Type

Single Medicine Product

Effective date

16/06/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

OZURDEX is indicated for the treatment of:,- Diabetic macular oedema (DME),- Macular oedema due to Branch Retinal Vein Occlusion (BRVO) or

Central Retinal Vein Occlusion (CRVO).,- Non-infectious uveitis affecting the posterior segment of the eye.

OZURDEX is indicated for the treatment of diabetic macular oedema (DME).

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Dispenser Pack

Not recorded

2 Years

Store below 25

degrees Celsius

Not recorded

Protect from Heat

Pack Size/Poison information

Pack Size

Poison Schedule

1 intravitreal implant

(S4) Prescription Only Medicine

Components

1. OZURDEX-dexamethasone

Dosage Form

Implant

Route of Administration

Intravitreal-Within The Vitreous Cavity Of The Eye

Visual Identification

Rod-shaped, solid implant in a single use applicator

Active Ingredients

Dexamethasone

700 microgram

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 26.11.2017 at 11:26:12 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet

OZURDEX

(dexamethasone) 700 µg implant V2.0

OZURDEX

®

(dexamethasone) 700 µg 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

you have an allergy to

dexamethasone or any of the

ingredients listed at the end of

this leaflet

you have an infection of any kind

in or around your eyes

(bacterial, viral, or fungal)

you have advanced glaucoma or

high pressure inside your eye

that cannot be controlled by

medications alone

the eye to be treated does not

have a lens and the back of the

lens capsule (“the bag”) has

been ruptured

the eye to be treated has a man-

made lens, which was implanted

in the front compartment of the

eye (anterior chamber

intraocular lens) after cataract

surgery, and the back of the lens

capsule (“the bag”) has been

ruptured.

Before you start to use it

Tell your doctor if:

you have had cataract surgery,

iris surgery (the coloured part of

the eye that controls the amount

of light that enters into the eye)

or surgery to remove the gel

(called the vitreous) from within

the eye.

you are taking any medicines to

thin the blood.

you are taking any steroid or

non-steroidal anti-inflammatory

medicines by mouth or applied

to the eye

you have had a herpes simplex

infection in your eye in the past

(an ulcer on the eye that has

been there a long time, or sores

on the eye).

you are pregnant or intend to

become pregnant.

Like most medicines,

OZURDEX

should not be used

during pregnancy, unless

clearly necessary.

you are breast-feeding or

intend to breast-feed.

Before you receive OZURDEX

treatment, your doctor should tell

you to immediately report any eye

pain, change in vision, red eyes or

sensitivity to light that occurs post-

procedure.

Taking other medicines

Tell your doctor if you are taking

any other medicines, including any

that you buy without a prescription

from your pharmacy, supermarket

or health food shop.

How OZURDEX

®

is used

All OZURDEX

injections will be

administered by an appropriately

qualified eye doctor.

OZURDEX

is administered as a

single injection into your eye under

sterile conditions. Before the

injection your doctor will use

antibiotic eye drops and clean the

surface of your eye carefully to help

prevent infection. Your doctor will

also give you a local anaesthetic to

reduce or prevent any pain you

might have with the injection. You

may hear a “click” during the

injection of OZURDEX

; this is

normal.

Afterwards your doctor may

perform some additional tests to

make sure there are no signs of

inflammation or infection of the eye

OZURDEX

(dexamethasone) 700 µg implant V2.0

and will monitor your vision and the

pressure in your eye.

If your condition is found to be

worsening, your doctor may

administer OZURDEX

again.

Follow all directions given to you by

your doctor carefully. The directions

may differ from the information

contained in this leaflet.

The injection of OZURDEX

into

both eyes at the same time has not

been studied and is not

recommended. Your doctor should

not inject OZURDEX

into both

eyes at the same time.

How long to use it

Your doctor will advise you and

decide how long you should be

treated with OZURDEX

If a dose is missed

If you miss an OZURDEX

appointment, you need to contact

your doctor as soon as possible to

arrange another appointment.

While you are using OZURDEX

®

Things you must do

Tell your doctor immediately if

you develop symptoms such as

the following after injection of

OZURDEX

®

:

blurred or decreased vision

eye pain or increased

discomfort

worsening eye redness

a feeling of spots in front of the

eye (sometimes called

“floaters”)

increased sensitivity to light

any discharge from the eye

In some patients the pressure in the

eye may increase for a short period

after the injection, or patients may

also develop an eye infection.

Increase in pressure in the eye can

also occur at any time following

injection, this is something you may

not notice so your doctor will

monitor you regularly after

treatment.

Before stopping OZURDEX

®

treatment

If you decide not to receive a repeat

OZURDEX

treatment, please go to

your next appointment and discuss

this with your doctor. Your doctor

will advise you and decide how long

you should be treated with

OZURDEX

Things you must not do

You may experience temporarily

reduced vision after being treated

with OZURDEX

. You should not

drive or operate machinery until

your vision has returned to normal.

Side effects

Tell your doctor as soon as possible

if you have any problems while

being treated with OZURDEX

even if you do not think the

problems are connected with the

medicine or are not listed in this

leaflet.

Like all medicines, OZURDEX

®

cause side effects, although not

everybody gets them.

Tell your doctor immediately if you

experience any of the following side

effects associated with OZURDEX

®

treatment:

Common side effects:

vision decrease caused

byclouding of the lens (cataract)

which may need a cataract

surgery

increased pressure in the eye

(as determined by the doctor)

which may need to be treated

with medicines or in a rare case

with a surgical procedure

bleeding on the surface of the

eye*

vision decrease or seeing

floaters due to bleeding inside of

the eye*

eye pain*

seeing flashes of light due to

detachment of the jelly inside

the eye from the light-sensitive

layer at the back of the eye

perception of having something

floating in the eye (floaters)*

swelling on the surface of the

eye*

inflammation in the front part of

the eye*

Uncommon side effects:

headache, tear of the light-sensitive

layer at the back of the eye (retinal

tear), severe inflammation at the

back of the eye (usually due to viral

infection), increased protein in the

front of the eye due to

inflammation, inflammation or

infection inside the eye, glaucoma,

eyelid itching, migraine.

* some of these side effects may be

caused by the injection procedure

and not the OZURDEX

implant

itself.

Ask your doctor any questions you

may have.

Product description

What OZURDEX

®

looks like:

OZURDEX

is a sterile rod shaped

implant containing 700 µg of

dexamethasone, located in the

stainless steel needle of a

disposable applicator.

Ingredients

Active ingredient:

Dexamethasone 700µg

Inactive ingredients:

Polyglactin, 50:50 PLGA ester

Polyglactin, 50:50 PLGA acid

Manufacturer/Supplier

ALLERGAN AUSTRALIA PTY LTD

810 Pacific Hwy

Gordon NSW 2072

ABN 85 000 612 831

Toll free: 1800 252 224 (Australia)

ALLERGAN NEW ZEALAND

LIMITED

Cnr Manu Tapu Drive & Joseph

Hammond Place,

Auckland International Airport,

New Zealand

Freephone: 0800 659 912 (NZ)

OZURDEX

can be identified by

registration number:

AUST R 222392

Date of preparation: June 2017

24-9-2018

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