국가: 뉴질랜드
언어: 영어
출처: Medsafe (Medicines Safety Authority)
Dexamethasone 700ug
AbbVie Limited
Dexamethasone 700 µg
700 mcg
Intraocular implant
Active: Dexamethasone 700ug Excipient: Polyglactin (poly (D, L-lactide-co-glycolide), 50:50 PLGA acid) Polyglactin
Applicator, pre-filled, single dose, The applicator containing the implant is packaged in a sealed foil pouch, 1 implant
Prescription
Prescription
Sanofi Chimie
OZURDEX® is indicated for the treatment of macular oedema due to Retinal Vein Occlusion (RVO).
Package - Contents - Shelf Life: Applicator, pre-filled, single dose, The applicator containing the implant is packaged in a sealed foil pouch - 1 implants - 36 months from date of manufacture stored at or below 25°C
2009-03-25
OZURDEX ® (dexamethasone) 700 µg intravitreal implant CMI V4.0 PI v6.0 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: i you have an allergy to dexamethasone or any 전체 문서 읽기
OZURDEX ® Intraocular implant DS v13 draft 1.0 CCDS v10.0 – clean changes – 19Jun2023 1 DATA SHEET 1. PRODUCT NAME OZURDEX ® 700 µg implant 2. QUALITATIVE AND QUANTITATIVE COMPOSITION dexamethasone 700 µg For full list of excipients, see section 6.1 List of Excipients. 3. PHARMACEUTICAL FORM Dexamethasone is a white to cream-coloured crystalline powder with not more than a slight odour, and is practically insoluble in water and very soluble in alcohol. OZURDEX ® is a biodegradable intravitreal implant containing 700 μg dexamethasone in the NOVADUR™ solid polymer drug delivery system. OZURDEX ® is preloaded into a single-use, specially designed drug delivery system (DDS) applicator to facilitate injection of the rod- shaped implant directly into the vitreous. The polymer drug delivery system contains polyglactin [poly (D,L-lactide-coglycolide)] PLGA biodegradable polymer matrix. OZURDEX ® is preservative-free. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS OZURDEX is indicated for the treatment of macular oedema due to retinal vein occlusion (RVO). 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. OZURDEX ® is indicated for the treatment of non-infectious uveitis affecting the posterior segment of the eye. 4.2 DOSE AND METHOD OF ADMINISTRATION Single-use intravitreal implant in applicator for intravitreal use only. Treatment with OZURDEX ® for retinal vein occlusion, diabetic macular oedema and uveitis is 700 µg per eye (entire contents of a single-use OZURDEX ® device). Repeat doses should be considered when a patient experiences a response to treatment followed subsequently by a loss in visual acuity and in the physician’s opinion may benefit from retreatment without being exposed to significant risk. Patients who experience and retain improved vision should not be retreated. Patients who experienc 전체 문서 읽기