Страна: Велика Британія
мова: англійська
Джерело: MHRA (Medicines & Healthcare Products Regulatory Agency)
Dexamethasone
Allergan Ltd
Dexamethasone
700microgram
Implant
Intravitreal
No Controlled Drug Status
Valid as a prescribable product
BNF: ; GTIN: 5016007203462
1 PACKAGE LEAFLET: INFORMATION FOR THE USER OZURDEX 700 MICROGRAMS INTRAVITREAL IMPLANT IN APPLICATOR dexamethasone READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor. See section 4. 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 OZURDEX is used 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 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 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. • 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. Swelling of the macula may lead to damage which affects your central vision which is used for tasks like reading. OZURDEX works by reducing this swelling of the macular which helps to lessen or prevent more damage to the macula. • Inflammation of the back of the eye. This inflammation leads to a decrease of vision and/or the presence of floaters in the eye, (black dots or wispy lines that move across the field of vision). OZURDEX works by reducing this inflammation. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN OZURDEX YOU Прочитайте повний документ
OBJECT 1 OZURDEX Summary of Product Characteristics Updated 29-Nov-2017 | Allergan Ltd 1. Name of the medicinal product OZURDEX 700 micrograms intravitreal implant in applicator 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. Disposable injection device, containing a rod-shaped implant. which is not visible. The implant is approximately 0.46 mm in diameter and 6 mm in length. 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) (see section 5.1) • 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 (see section 4.4). _DME _ Patients treated with OZURDEX who have experienced an initial response and in the physician's opinion may benefit from retreatment without being exposed to significant risk should be considered for retreatment. Retreatment may be performed after approximately 6 months if the patient experiences decreased vision and/or an increase in retinal thickness, secondary to recurrent or worsening diabetic macular oedema. There is currently no experience of the efficacy or safety of repeat administrations in DME beyond 7 implants. _RVO and uveitis _ Repeat doses should be considered when a patient experiences a response to treatment followed subsequently by a lo Прочитайте повний документ