Land: Australien
Språk: engelska
Källa: Department of Health (Therapeutic Goods Administration)
Aflibercept, Quantity: 40 mg/mL
Bayer Australia Ltd
Aflibercept
Injection, solution
Excipient Ingredients: monobasic sodium phosphate monohydrate; sucrose; polysorbate 20; sodium chloride; water for injections; dibasic sodium phosphate heptahydrate
Intravitreal-Within The Vitreous Cavity Of The Eye
1 vial (commercial pack), 1 vial (Physician's sample pack)
(S4) Prescription Only Medicine
EYLEA (aflibercept) is indicated in adults for the treatment of: - neovascular (wet) age-related macular degeneration (wet AMD); - visual impairment due to macular oedema secondary to central retinal vein occlusion (CRVO); - diabetic macular oedema (DME); - visual impairment due to macular oedema secondary to branch retinal vein occlusion (BRVO); - visual impairment due to myopic choroidal neovascularisation (myopic CNV)
Visual Identification: EYLEA is a sterile, clear, colourless to pale yellow, preservative-free, iso-osmotic aqueous 40 mg/mL solution for intravitreal injection.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2012-03-07
EYLEA CMI VX1.0 Page 1 of 5 EYLEA ® (EYE • LEAH) _AFLIBERCEPT (RCH) _ _ _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about EYLEA. 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 being given EYLEA against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET. You may need to read it again. WHAT EYLEA IS USED FOR EYLEA is used to treat eye conditions in adults for: • Neovascular wet age-related macular degeneration (also known as wet AMD) • visual impairment due to macular oedema after central retinal vein occlusion (also known as CRVO) • visual impairment due to macular oedema after branch retinal vein occlusion (also known as BRVO) • diabetic macular oedema (DME), which is a swelling of the retina occurring in patients with diabetes • visual impairment due to myopic choroidal neovascularisation (also known as myopic CNV), which is associated with a severe form of short sightedness. Wet AMD is a condition in which abnormal blood vessels grow in the back of the eye (retina). These blood vessels can leak blood and fluid into the retina and damage it leading to vision loss. CRVO is caused by a blockage in the main blood vessel that transports blood away from the retina, in the back of your eye. The blockage stops blood from flowing in and out of the retina which causes swelling (macular oedema) and can damage your eyesight. DME is a swelling of the retina occurring in patients with diabetes due to leakage of fluid from blood vessels within the retina. When the macula swells with fluid, central vision becomes blurry. BRVO is caused by a blockage in one or more branches of the main blood vessel that transports blood away from the retina, in the back of your eye. The blockage stops blood from flowing in and Läs hela dokumentet
CCDS 14 VX4.0; 04 Nov 2021 Page 1 of 36 AUSTRALIAN PRODUCT INFORMATION EYLEA ® AFLIBERCEPT (RCH) SOLUTION FOR INTRAVITREAL INJECTION 1. NAME OF THE MEDICINE Aflibercept (rch) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 mL of EYLEA solution contains 40 mg aflibercept. Each vial and pre-filled syringe provides a usable amount to deliver a single dose of 50 µL solution for intravitreal injection containing 2 mg aflibercept. Aflibercept is a recombinant fusion protein consisting of portions of human VEGF receptor 1 and 2 extracellular domains fused to the Fc portion of human IgG1. Aflibercept is produced in Chinese hamster ovary (CHO) K1 cells by recombinant DNA technology. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3. PHARMACEUTICAL FORM Solution for intravitreal injection. EYLEA is a sterile, clear, colourless to pale yellow, preservative-free, iso-osmotic aqueous solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS EYLEA (aflibercept) is indicated in adults for the treatment of: • neovascular (wet) age-related macular degeneration (wet AMD) • visual impairment due to macular oedema secondary to central retinal vein occlusion (CRVO) • visual impairment due to macular oedema secondary to branch retinal vein occlusion (BRVO) • diabetic macular oedema (DME) • visual impairment due to myopic choroidal neovascularisation (myopic CNV). 4.2 DOSE AND METHOD OF ADMINISTRATION EYLEA is for intravitreal injection only. It must only be administered by a qualified ophthalmologist experienced in administering intravitreal injections. DOSAGE The recommended dose for EYLEA is 2 mg aflibercept, equivalent to an injection volume of 50 µL. The interval between doses injected into the same eye should not be shorter than one month. CCDS 14 VX4.0; 04 Nov 2021 Page 2 of 36 Advice on treatment initiation and maintenance of therapy specific to each patient population is described in the section below. Once optimal visual acuity is achieved and/or there are no signs of disease activity, Läs hela dokumentet