Država: Australija
Jezik: engleski
Izvor: Department of Health (Therapeutic Goods Administration)
dexamethasone, Quantity: 700 microgram
Abbvie Pty Ltd
Dexamethasone
Implant
Excipient Ingredients: polyglactin
Intravitreal-Within The Vitreous Cavity Of The Eye
1 intravitreal implant
(S4) Prescription Only Medicine
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).
Visual Identification: Rod-shaped, solid implant in a single use applicator; Container Type: Dispenser Pack; Container Material: Other plastic laminate/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2015-06-04
OZURDEX ® (dexamethasone) 700 µg intravitreal implant CMI V3.0 PI v5.0 1 OZURDEX ® (DEXAMETHASONE) 700 ΜG INTRAVITREAL 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 ® if: you have an allergy to dexamethasone o Pročitajte cijeli dokument
OZURDEX ® Intravitreal implant PI v5.0 CCDS v7.0-8.0-9.0 1 AUSTRALIAN PRODUCT INFORMATION – OZURDEX ® (DEXAMETHASONE) INTRAVITREAL IMPLANT 1 NAME OF THE MEDICINE Dexamethasone 2 QUALITATIVE AND QUANTITATIVE COMPOSITION OZURDEX ® is a biodegradable intravitreal implant containing 700 μg dexamethasone in a solid polymer drug delivery system (DDS). For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Intravitreal implant 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC 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. 4.2 DOSE AND METHOD OF ADMINISTRATION The safety and efficacy of OZURDEX ® administered to both eyes on the same day has not been studied; and is not recommended. OZURDEX ® must be administered by a qualified ophthalmologist, experienced in intravitreal insertions. Treatment with OZURDEX ® for diabetic macular oedema, macular oedema following BRVO or CRVO, and non-infectious uveitis affecting the posterior segment of the eye is 700 µg per eye (entire contents of a single-use OZURDEX ® device). If, in the physician’s opinion, visual and anatomic parameters indicate that the patient is not benefitting from continued treatment, OZURDEX ® should be discontinued. OZURDEX ® Intravitreal implant PI v5.0 CCDS v7.0-8.0-9.0 2 DME In clinical trials, the majority of retreatments were administered between 5 and 7 months after a prior treatment (see CLINICAL TRIALS ). Patients in the OZURDEX ® arm of the pivotal trials received an average of 4 implants over 3 years. The protocol in the pivotal trials specified a 6-monthly dosing interval. There is currently no experience of the efficacy and safety of repeat administrations in DME beyond 7 implants. RVO AND UVEITIS OZURDEX ® should be used in BRVO or CRVO patients with reduced visual acuity only when other Pročitajte cijeli dokument