Država: Velika Britanija
Jezik: angleščina
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ranibizumab
Novartis Pharmaceuticals UK Ltd
S01LA04
Ranibizumab
10mg/1ml
Solution for injection
Intravitreal
No Controlled Drug Status
Valid as a prescribable product
BNF: ; GTIN: 5010678912067
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT LUCENTIS ® 10 MG/ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE ranibizumab 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 you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Lucentis is and what it is used for 2. What you need to know before you are given Lucentis 3. How Lucentis is given 4. Possible side effects 5. How to store Lucentis 6. Contents of the pack and other information 1. WHAT LUCENTIS IS AND WHAT IT IS USED FOR WHAT LUCENTIS IS Lucentis is a solution which is injected into the eye. Lucentis belongs to a group of medicines called antineovascularisation agents. It contains the active substance called ranibizumab. WHAT LUCENTIS IS USED FOR Lucentis is used in adults to treat several eye diseases causing vision impairment. These diseases result from damage to the retina (light-sensitive layer at the back of the eye) caused by: - Growth of leaky, abnormal blood vessels. This is observed in diseases such as age-related macular degeneration (AMD). It may also be associated with choroidal neovascularisation (CNV) due to pathologic myopia (PM), angioid streaks, central serous chorioretinopathy or inflammatory CNV. - Macular oedema (swelling of the centre of the retina). This swelling can be caused by diabetes (a disease called diabetic macular oedema (DME)) or by the blockage of retinal veins of the retina (a disease called retinal vein occlusion (RVO)). HOW LUCENTIS WORKS Lucentis specifically recognises and binds to a protein called human vascular endothelial growth factor A (VEGF-A) present in the eye. In excess, VEGF-A causes abnormal blood vessel growth and swelling in the eye which can lead to impairment of vision in diseases like AMD, PM, CNV, DME or RVO. By bindi Preberite celoten dokument
OBJECT 1 LUCENTIS 10 MG/ML SOLUTION FOR INJECTION IN PRE- FILLED SYRINGE Summary of Product Characteristics Updated 18-May-2018 | Novartis Pharmaceuticals UK Ltd 1. Name of the medicinal product Lucentis ® 10 mg/ml solution for injection in pre-filled syringe 2. Qualitative and quantitative composition One ml contains 10 mg ranibizumab*. One pre-filled syringe contains 0.165 ml, equivalent to 1.65 mg ranibizumab. The extractable volume of one pre-filled syringe is 0.1 ml. This provides a usable amount to deliver a single dose of 0.05 ml containing 0.5 mg ranibizumab. *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. 3. Pharmaceutical form Solution for injection. Clear, colourless to pale yellow aqueous solution. 4. Clinical particulars 4.1 Therapeutic indications Lucentis is indicated in adults for: • The treatment of neovascular (wet) age-related macular degeneration (AMD) • The treatment of visual impairment due to choroidal neovascularisation (CNV) • The treatment of visual impairment due to diabetic macular oedema (DME) • The treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) 4.2 Posology and method of administration Lucentis must be administered by a qualified ophthalmologist experienced in intravitreal injections. Posology 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 be at least four weeks. Treatment is initiated with one injection per month until maximum visual acuity is achieved and/or there are no signs of disease activity i.e. no change in visual acuity and in other signs and symptoms of the disease under continued treatment. In patients with wet AMD, DME and RVO, initially, three or more consecutive, monthly injections may be needed. Thereafter, monit Preberite celoten dokument