700 micrograms intravitreal implant in applicator
dexamethasone
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:
- Loss of vision due to diabetic macular edema (DME) if you have already had cataract surgery or if you have not previously responded or are not suitable for other treatments. Diabetic macular edema is a swelling in the photosensitive layer in the back of the eye called the macula. DME is a condition that affects some people with diabetes.
- Loss of vision in adults is caused by blockage of veins in the eye. This blockage causes fluid to accumulate, leading to swelling of the part of the retina (the light-sensitive layer at the back of the eye) called the macula.
Swelling in the macula can lead to injuries, which can affect the central vision that you use e.g. when reading. OZURDEX works by reducing the swelling in the macula and thus helps to reduce or prevent damage to it. - Inflammation of the back of the eye. This inflammation leads to impaired vision and/or the presence of liquid clouding in the eye (black dots or tangled lines moving across the visual field ). OZURDEX works by reducing this inflammation.
What you need to know before using OZURDEX
Do not use OZURDEX
- if you are allergic to dexamethasone or any of the other ingredients of this medicine (listed in section 6)
- if you have an infection of any kind in or around the eye (bacteria, virus, or fungus)
- if you have glaucoma or high pressure in the eye that cannot be treated properly with the medicines you may be using.
- if the eye to be treated lacks a lens and if the back of the lens capsule has ruptured
- if the eye to be treated has undergone cataract surgery and has an artificial lens, which is implanted in the anterior cavity of the eye ( intraocular lens in the anterior chamber) or has been fixed to the white part of the eye (sclera) or the colored part of the eye ( iris ) and the back of the lens capsule has burst
Warnings and cautions
Before injecting one with OZURDEX, tell your doctor about:
- you have undergone cataract surgery, iris surgery (the colored part of the eye that controls the amount of light that enters the eye), or surgery to remove the fluid inside the eye ( vitreous one)
- you are taking some blood thinners
- you are taking any steroid or non-steroidal anti-inflammatory drugs that are taken by mouth or applied to the eye
- you have previously had a herpes simplex infection in the eye (a wound on the eye that has been there for a long time, or a red and inflamed eye)
Occasionally, injection of OZURDEX may cause an infection inside the eye, pain in the eye or red eye, or a rupture or loosening of the retina. It is important to ascertain and treat these as soon as possible. Tell your doctor immediately if you experience increased eye pain or increased discomfort in the eye, eye redness that gets worse, flashes of light and a sudden increase in fluid cloudiness in the eye, partially blocked vision, impaired vision, or increased photosensitivity after injection.
In some patients, pressure in the eye may increase and possibly cause glaucoma. This can happen without you noticing and the doctor will therefore examine you regularly and, if necessary, give you treatment to reduce the pressure in your eye.
In most patients who have not yet undergone cataract surgery, a cloudiness of the eye’s natural lens ( cataract ) may occur after repeated treatment with OZURDEX. If this happens, your vision will deteriorate and you will probably need to have surgery to remove the cataract. Your doctor will help you decide when it is most appropriate to operate, but you should be aware that until you are ready for your operation, your vision will be as bad or worse than it was before you started receiving your OZURDEX. injection is.
The implant can be moved from the back of the eye to its front in patients with a rupture in the back of the lens capsule and/or patients who have an opening in the iris. This can lead to swelling in the transparent layer in front of the eye and cause blurred vision. If this continues for a long time and is not treated, it may be necessary to perform tissue transplantation.
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.
Children and adolescents (under 18 years)
The use of OZURDEX in children and adolescents has not been studied and is therefore not recommended.
Other medicines and OZURDEX
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and breastfeeding
There is no experience with the use of OZURDEX in pregnant women or during breastfeeding. OZURDEX should not be used during pregnancy or breastfeeding unless your doctor considers it necessary. If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, talk to your doctor before taking OZURDEX. Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
After treatment with OZURDEX, your vision may be slightly impaired for a short time. If this happens, do not drive or use any tools or machines until your eyesight has improved.
How to use OZURDEX
All OZURDEX injections will be given by an ophthalmologist with appropriate training.
The recommended dose is an implant that is injected into your eye. If the effect of the injection should decrease and if the doctor recommends it, another implant can be injected into the eye.
Your doctor will ask you to use eye drops with antibiotics daily for three days before and after each injection to prevent eye infection. Follow these instructions carefully.
On the day of injection, your doctor may use eye drops with antibiotics to prevent infection. Your doctor will clean your eye and eyelids before injecting one. Your doctor will also give you local anesthesia to reduce or prevent any pain when you inject one. You may hear a clicking sound when OZURDEX is injected. This is normal.
Detailed instructions for the doctor on how to inject one of OZURDEX are included in the carton of the medicine.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects can be seen with OZURDEX:
Very common (may affect more than 1 in 10 people):
Increased pressure in the eye, cloudy lens ( cataract ), bleeding on the surface of the eye *
Common (may affect up to 1 in 10 people):
High pressure in the eye, turbidity at the back of the lens, bleeding on the inside of the eye *, impaired vision *, difficulty seeing, discharge of the gelatinous mass inside the eye from the photosensitive layer at the back of the eye (vitreous detachment) *, a feeling of spots in the front eye (including liquid haze) *, a feeling of seeing through haze or fog *, inflammation of the eyelid, eye pain *, flashes of light *, swelling in the layer over the white part of the eye *, redness of the eyes *, headache
Uncommon (may affect up to 1 in 100 people):
A severe inflammation in the back of the eye (usually due to a viral infection), severe infection or inflammation inside the eye *, glaucoma (an eye disease where increased pressure inside the eye is associated with damage to the optic nerve ), discharge of the photosensitive layer at the back of the eye (retinal detachment) *, rupture of the photosensitive layer at the back of the eye (retinal rupture) *, decreased pressure in the eye in connection with leakage of the gelled mass ( vitreous one) from the inside of the eye *, inflammation inside 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 *, itchingon the eyelid, redness in the white part of the eye *, movement of the OZURDEX implant et from the back of the eye to the front part which leads to blurred vision or impaired vision and which may cause swelling in the transparent part of the eye (cornea) *, unintentional incorrect placement of OZURDEX implant *, migraine
* These side effects may be due to the injection procedure and not the OZURDEX implant itself. The more injections you receive, the more often these side effects may occur.
How to store OZURDEX
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and bag after EXP: The expiration date is the last day of the specified month.
No special storage instructions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is dexamethasone.
- Each implant contains 700 micrograms of dexamethasone.
- The other ingredients are Ester-terminated 50:50 poly D, L-lactide-glycolide copolymer, and acid-terminated 50:50 poly D, L-lactide-glycolide copolymer.
What the medicine looks like and the contents of the pack
OZURDEX is a rod-shaped implant that is stored inside a needle in an applicator. The applicator and a pack of desiccants are packed in a sealed foil bag in a carton. A carton contains an applicator with an implant to be used once and then discarded.
Marketing Authorization Holder and Manufacturer
Allergan Pharmaceuticals Ireland
Castlebar Road
Westport
Co. Mayo
Ireland
For any information about this medicine, please contact the local representative of the Marketing Authorization Holder:
| België / Belgique / Belgien /Luxembourg / LuxemburgAllergan nvTel: +32 (0) 2 351 24 24 | LithuaniaAbbVie UABTel: +370 5 205 3023 |
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| DenmarkAllergan Norden ABTel: + 4580884560 | NorwayAllergan Norden ABTel: +47 80 01 04 97 |
| GermanyAllergan GmbHTel: +49 69 92038 1050 | Austria Pharm-Allergan GmbHTel: +43 1 99460 6355 |
| EestiAbbVie OÜTel: + 372 623 1011 | PolandAllergan Sp. z ooTel .: +48 22 256 3700 |
| Greece / CyprusAllergan Hellas Pharmaceuticals SA :ηλ: +30 210 74 73 300 | PortugalProfarin Lda.Tel: + 351 21 425 3242 |
| SpainAllergan SATel: + 34 91 807 6130 | RomaniaAllergan SRLTel: +40 21 301 53 02 |
| FranceAllergan France SASTel: +33 (0) 1 49 07 83 00 | SloveniaAbbVie Biofarmacevtska družba dooTel: + 386 (1) 32 08 060 |
| CroatiaAbbVie dooTel: +385 (0) 1 5625 501 | Slovak RepublicAllergan SK sroTel: +421 800 221 223 |
| Ireland / Malta / United Kingdom (Northern Ireland)Allergan Pharmaceuticals IrelandTel: +3531800 931 787 (IE)+356 27780331 (MT)+44 (0) 1628 494026 (UK (NI)) | Finland / FinlandAllergan Norden ABPuh / Tel: + 358 800 115 003 |
| IcelandTeva Pharma Iceland ehf.Phone: +354 550 3300 | SwedenAllergan Norden ABTel: + 46859410000 |
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