País: Nova Zelândia
Língua: inglês
Origem: Medsafe (Medicines Safety Authority)
Ranibizumab 10 mg/mL
Novartis New Zealand Ltd
Ranibizumab 10 mg/mL
10 mg/mL
Solution for injection
Active: Ranibizumab 10 mg/mL Excipient: Histidine Histidine hydrochloride Polysorbate 20 Trehalose dihydrate Water for injection
Vial, single dose, (0.23 mL) +filtration needle + inj needle + syringe, 0.23 mL
Prescription
Prescription
Roche Singapore Technical Operations
Lucentis® is indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD).
Package - Contents - Shelf Life: Syringe, glass, - 0.165 mL - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 24 hours unopened stored at or below 25°C. blister tray is unopened - Vial, single dose, (0.23 mL) with or without admin kit - 0.23 mL - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 24 hours unopened stored at or below 25°C protect from light. blister unopened
2006-03-20
Lucentis 1 LUCENTIS _Ranibizumab (rbe) _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Lucentis. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. The information in this leaflet was last updated on the date listed on the final page. More recent information on the medicine may be available. YOU SHOULD ENSURE THAT YOU SPEAK TO YOUR PHARMACIST OR DOCTOR TO OBTAIN THE MOST UP-TO-DATE INFORMATION ON THE MEDICINE. YOU CAN ALSO DOWNLOAD THE MOST UP-TO- DATE LEAFLET FROM WWW.MEDSAFE.GOVT.NZ Those updates may contain important information about the medicine and its use of which you should be aware. All medicines have risks and benefits. Your doctor has weighed the risks of you being given Lucentis 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 LUCENTIS IS USED FOR Lucentis is used to treat problems with your vision due to damage to the retina (light-sensitive layer at the back of the eye) caused by growth of leaky, abnormal blood vessels (choroidal neovascularisation, CNV), in diseases that may cause decreased vision such as: • Wet age related macular degeneration (wet AMD) • Diabetic macular edema (DME), or edema due to retinal vein occlusion (RVO) where fluid accumulates into the back of the eye • Proliferative diabetic retinopathy (PDR) • CNV secondary to pathologic myopia (PM) • CNV due to other causes, such as angioid streaks, post- inflammatory retinochoroidopathy, central serous chorioretinopathy, and inflammatory CNV Lucentis contains the active substance ranibizumab, which is 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 re Leia o documento completo
NEW ZEALAND DATA SHEET Page 1 of 36 1 PRODUCT NAME LUCENTIS® Ranibizumab 10 mg/mL solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance One mL contains 10 mg ranibizumab. VIAL Each vial contains 2.3 mg of ranibizumab in 0.23 mL solution. PRE-FILLED SYRINGE Each pre-filled syringe contains 1.65 mg of ranibizumab in 0.165 mL solution. Ranibizumab is a humanised monoclonal antibody fragment produced in Escherichia coli cells by recombinant DNA technology. For the full list of excipients, see section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Solution for injection. Lucentis is supplied in a vial or a pre-filled syringe. VIAL Sterile, clear, colourless to pale yellow to brown and preservative-free aqueous solution. PRE-FILLED SYRINGE Sterile, clear, colourless to pale yellow to brown and preservative-free aqueous solution. 4 CLINICAL PARTICULARS 4.1 Therapeutic indications Lucentis® is indicated for: • the treatment of neovascular (wet) age-related macular degeneration (AMD) • the treatment of visual impairment due to diabetic macular oedema (DME) • the treatment of proliferative diabetic retinopathy (PDR) • the treatment of visual impairment due to choroidal neovascularization, • the treatment of visual impairment due to choroidal neovascularisation (CNV) secondary to pathologic myopia (PM) • the treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO). 4.2 Dose and method of administration Dosage regimen Single-use vial for intravitreal use only. Use of more than one injection from a vial can lead to product contamination and subsequent ocular infection. Lucentis must be administered by a qualified ophthalmologist experienced in intravitreal injections. NEW ZEALAND DATA SHEET Page 2 of 36 The recommended dose for Lucentis is 0.5 mg given as a single intravitreal injection. This corresponds to an injection volume of 0.05 mL. The interval between two doses injected into the same eye should not be shorter than one Leia o documento completo