Ozurdex 700mcg.

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 adults with:

Loss of vision due to diabetic macular edema (DOM) - if you are already a drapery or have not responded or are not suitable for other treatments. Diabetic edema of the macula is a swelling of the light-sensitive layer at the back of the eye called the macula. HOME is a condition that affects some people with diabetes;
Loss of vision in adults caused by occlusion of veins in the eye. This blockage leads to fluid build-up, which causes 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 result in damage affecting central vision used for tasks such as reading. OZURDEX works by reducing the edema of the macula, helping to reduce or prevent its damage;
Inflammation of the back of the eye. This inflammation leads to diminished vision and / or the presence of floating clouds in the eye (black spots or thin lines that move through the field of vision). OZURDEX works by reducing this inflammation.

2. What you need to know before you are given OZURDEX
You should not be given OZURDEX:

if you are allergic (hypersensitive) to dexamethasone or any of the other ingredients of OZURDEX (for a full list of excipients, see section 6 "ADDITIONAL INFORMATION");
if you have any infection in or around the eye (bacterial, viral or fungal);
if you have glaucoma or increased pressure inside the eye that is not adequately controlled with the medicines you may be using;
if the eye to be treated has no lens and the back of the lens capsule ("sac") is torn;
if the eye to be treated is operated for a curtain and has an artificial lens that is implanted in the anterior segment of the eye (intraocular lens in the anterior chamber) or is fixed to the white part of the eye (sclera) or to the colored part of the eye iris) and the back of the lens capsule ("the bag") is torn.
Warnings and precautions
Before you inject OZURDEX, tell your doctor if:

You have a dragonfly operation, an iris operation (the colored part of the eye controlling the amount of light that enters the eye) or an operation to remove the gel (called vitreous body) from the inside of the eye;
you are taking any medication that dilutes the blood;
take any steroidal or non-steroidal anti-inflammatory drugs orally or in the eye;
you have had a herpes simplex infection in the eye (an ulcer of the eye that has been held for a long time, or an enlargement of the eye).
Sometimes injection of OZURDEX may cause eye infection, pain or redness of the eye, or peeling or tearing of the retina. It is important that they are identified and treated as early as possible. Please tell your doctor immediately if you develop severe pain in the eye or a severe unpleasant sensation, worsening eye flushing, sparking vision, and sudden increase in driftiness, partially blocked vision, reduced vision, or increased sensitivity to light after injection.
In some patients, ocular pressure may increase with possible development of glaucoma. This is something you may not notice, so your doctor will monitor you regularly and, if necessary, apply eye reduction treatment.
In most patients who have not yet been treated for a curtain, after opaque treatment with OZURDEX, clouding of natural eye lenses (curtains) may develop. If this happens, your vision will lose weight and you will most likely need a curtain removal operation. Your doctor will help you decide when the time is right for this surgery, but you should know that while you are ready for this surgery your vision may be as bad or even worse than it was before you started you get injections with OZURDEX.
The implant can be shifted from the rear to the front of the eye in patients with a tear in the back of the lens capsule and / or those with a hole in the iris. This may lead to edema of the transparent layer at the front of the eye and cause blurred vision. If it lasts long and is left untreated, tissue transplantation may be necessary.
Injection of OZURDEX to both eyes is not currently studied and is not recommended. Your doctor should not inject OZURDEX in both eyes at the same time.

Children and adolescents (under 18 years of age)
The use of OZURDEX in children and adolescents has not been studied and is therefore not recommended.

Other medicines and OZURDEX
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy, breastfeeding and fertility
There is no experience of use
Detailed instructions for your doctor on how to put the OZURDEX injection are provided in the carton of the product.

If you have any further questions on the use of this medicine, ask your doctor.

4. Possible side effects
Like all medicines, OZURDEX can cause side effects, although not everyone gets them.

The frequency of possible side effects listed below is determined according to the following conditions:

Very common: affects more than 1 user in 10;
Common: affects 1 to 10 users in 100;
Uncommon: affects 1 to 10 users in 1,000;
Rare: affects 1 to 10 users in 10,000;
Very rare: affects less than 1 user in 10,000;
Not known: frequency can not be estimated from the available data.
The following side effects may occur with OZURDEX:
Adverse drug reactions

Very common: Elevated eye pressure, lens haze (curtains), bleeding on the surface of the eye *;
Common: High eye pressure, blurring in the back of the lens, bleeding inside the eye *, deterioration in vision, difficulty in clear vision, peeling of the iron-like structure in the eye from the light-sensitive layer at the back of the eye (vitreous detachment) sensation of spotting in the front of the eye (including "floating particles") *, sensation such as when looking through steam or mist *, eyelid inflammation, eye pain *, sparkle vision * swelling of the layer above the white part of the eye * , edema of the surface of the eye *, headache;
Uncommon: Severe inflammation in the back of the eye (usually due to viral infection), serious infection or inflammation inside the eye, glaucoma (eye disease where the pressure in the eye is associated with optic nerve damage), peeling of the light-sensitive layer (retinal detachment), rupture of the light-sensitive layer at the back of the eye (retinal rupture) *, decrease in eye pressure associated with leakage of the iron-like structure (vitreous body) from inside eye irritation *, inflammation in the front of the eye, increased amount of protein and cells in the front of the eye due to inflammation *, abnormal sensation in the eye *, itching of the eyelid, reddening of the white part of the eye, migration of the implant OZURDEX from the rear to the front of the eye, which causes blurred or diminished vision, and which could cause or cause edema of the transparent part of the eye (cornea) *, accidental implantation of the OZURDEX * implant, migraine.
* Some of these side effects may be caused by the injection procedure and not by the OZURDEX implant itself. The more injections you are given, the more likely these reactions may occur.
Reporting of side effects
If you get any side effects, talk to your doctor. This includes all possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system. As you report side effects, you can contribute to getting more information about the safety of this medicine.

5. How to store OZURDEX
Keep out of the reach and sight of children.
Do not use OZURDEX after the expiry date which is stated on the carton and envelope after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of your unnecessary medicines. These measures will help to protect the environment.

6. Package Contents and Additional Information
What OZURDEX contains
The active substance is dexamethasone.
Each implant contains 700 micrograms of dexamethasone.
The other ingredients are 50:50 poly-D, L-lactide-co-glycolide with an ester end group and 50:50 poly-D, L-lactide-co-glycolide with a carboxyl terminal group.

What OZURDEX looks like and contents of the pack
OZURDEX is a rod implant that is located in the applicator needle. The applicator and dryer sack are sealed in an envelope of foil wrapped in cardboard packaging.
One carton contains one applicator with one implant, which is used once and discarded.

 

 

 

 

 

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