Country: Մալայզիա
language: անգլերեն
source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Ranibizumab
NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.
Ranibizumab
1units Units
NOVARTIS PHARMA STEIN A.G.
_Consumer Medication Information Leaflet (RiMUP) _ LUCENTIS ® RANIBIZUMAB 10mg/mL solution for injection in pre-filled syringe 1 WHAT IS IN THIS LEAFLET 1. WHAT LUCENTIS IS USED FOR 2. HOW LUCENTIS WORKS 3. BEFORE YOU TAKE LUCENTIS 4. HOW TO USE LUCENTIS 5. WHILE USING LUCENTIS 6. SIDE EFFECTS 7. STORAGE AND DISPOSAL OF LUCENTIS 8. PRODUCT DESCRIPTION 9. MANUFACTURER AND PRODUCT REGISTRATION HOLDER 10. DATE OF REVISION WHAT LUCENTIS IS USED FOR Lucentis is a solution given by your ophthalmologist (eye doctor) as an injection into the eye under a local anesthetic. Lucentis is used to treat damage to the retina caused by growth of leaky, abnormal blood vessels (choroidal neovascularization, CNV) in diseases such as: Wet age related macular degeneration (wet AMD) CNV secondary to pathologic myopia (PM) CNV due to other causes, such as angioid streaks, post-inflammatory retinochoroidopathy, central serous chorioretinopathy, and inflammatory CNV Diabetic macular edema (DME), or edema due to retinal vein occlusion (RVO) where fluid accumulates into the back of the eye. HOW LUCENTIS WORKS Lucentis contains the active substance ranibizumab, which is a part of an antibody. Antibodies are proteins which specifically recognise and bind to other unique proteins in the body. Ranibizumab binds selectively to a protein called human vascular endothelial growth factor A (VEGF-A), which is present in the retina (the light- sensitive back part of the eye). Ranibizumab reduces both the growth and the leakage of new blood vessels in the eye, abnormal processes that contribute to the progression of wet age-related macular degeneration (wet AMD) or pathologic myopia (PM, a type of severe and progressive nearsightedness), and the development of macular edema (swelling) due to either diabetes (diabetic macular edema, DME) or retinal vein occlusion (RVO). BEFORE YOU USE LUCENTIS Follow all the doctor’s instructions carefully. They may differ from the general information contained in this leaflet. _When you must not use read_full_document
Drug Regulatory Affairs LUCENTIS ( ranibizumab) 10 mg/mL solution for injection in pre-filled syringe Malaysian Package Insert – (Oct 2017) (0.165 mL volume) IPL Author : Reema Rajaneesh CDS Author (s): Q Luethi -Peng , T. Armstrong GLC approval: 30 September 2014, amended 15 -Sep -2015, 10- Nov -2015, 28 -Jun -2016 and 25 -Sep -2017 Release date: 6-Oc≥ -2017 Tracking Number: Not Applicable Document status: Final Number of pages: 36 read_full_document