国家: 英国
语言: 英文
来源: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ciclosporin
Novartis Pharmaceuticals UK Ltd
L04AD01
Ciclosporin
100mg
Oral capsule
Oral
No Controlled Drug Status
Caution - AMP level prescribing advised
BNF: 08020200; GTIN: 5013054140085
PACKAGE LEAFLET: INFORMATION FOR THE USER NEORAL ® 25MG SOFT GELATIN CAPSULES NEORAL ® 50MG SOFT GELATIN CAPSULES NEORAL ® 100MG SOFT GELATIN CAPSULES (CICLOSPORIN) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 or pharmacist. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. The name of this product is Neoral 25mg Soft Gelatin Capsules, Neoral 50mg Soft Gelatin Capsules or Neoral 100mg Soft Gelatin Capsules, but will be referred to as Neoral Capsules or Neoral throughout the remainder of this leaflet. Also available in 10mg strength. WHAT IS IN THIS LEAFLET 1. What Neoral is and what it is used for 2. What you need to know before you take Neoral 3. How to take Neoral 4. Possible side effects 5. How to store Neoral 6. Contents of the pack and other information 1. WHAT NEORAL IS AND WHAT IT IS USED FOR WHAT NEORAL IS The name of your medicine is Neoral. It contains the active substance ciclosporin. This belongs to a group of medicines known as immunosuppressive agents. These medicines are used to lower the body’s immune reactions. WHAT NEORAL IS USED FOR AND HOW NEORAL WORKS IF YOU HAVE HAD AN ORGAN TRANSPLANT, BONE MARROW AND STEM CELL TRANSPLANTATION, the function of Neoral is to control your body’s immune system. Neoral prevents rejection of transplanted organs by blocking the development of certain cells which would normally attack the transplanted tissue. IF YOU HAVE AN AUTOIMMUNE DISEASE, in which your body’s immune response attacks your body’s own cells, Neoral stops this immune reaction. Such diseases include eye problems which threaten your vision (endogenous uv 阅读完整的文件
OBJECT 1 NEORAL SOFT GELATIN CAPSULES Summary of Product Characteristics Updated 10-Mar-2016 | Novartis Pharmaceuticals UK Ltd 1. Name of the medicinal product NEORAL ® Soft Gelatin Capsules Neciclopin ® Soft Gelatin Capsules 2. Qualitative and quantitative composition Each capsule contains 10 mg, 25 mg, 50 mg or 100 mg ciclosporin. Excipients with known effect: NEORAL Soft Gelatin Capsules contain: Ethanol: 11.8% v/v ethanol (9.4% m/v) (10mg, 25mg, 50 mg and 100 mg capsules). Propylene glycol: 10 mg/capsule (10 mg capsules); 25 mg/capsule (25 mg capsules); 50 mg/capsule (50 mg capsules); 100 mg/capsule (100 mg capsules). Macrogolglycerol hydroxystearate/Polyoxyl 40 hydrogenated castor oil: 40.5 mg/capsule (10 mg capsules), 101.25 mg/capsule (25 mg capsules), 202.5 mg/capsule (50 mg capsules), 405.0 mg/capsule (100 mg capsules). For the full list of excipients see section 6.1. 3. Pharmaceutical form Capsule, soft Neoral Soft Gelatin Capsules 10mg: Yellow-white, oval soft gelatin capsules, imprinted NVR 10 in red. Neoral Soft Gelatin Capsules 25mg: Blue-grey, oval soft gelatin capsules, imprinted with NVR 25mg in red. Neoral Soft Gelatin Capsules 50mg: Yellow-white, oblong soft gelatin capsules, imprinted with NVR 50mg in red. Neoral Soft Gelatin Capsules 100mg: Blue-grey, oblong soft gelatin capsules, imprinted with NVR 100mg in red. 4. Clinical particulars 4.1 Therapeutic indications Transplantation indications _Solid organ transplantation_ Prevention of graft rejection following solid organ transplantation. Treatment of transplant cellular rejection in patients previously receiving other immunosuppressive agents. _Bone marrow transplantation_ Prevention of graft rejection following allogeneic bone marrow and stem cell transplantation. Prevention or treatment of graft-versus-host disease (GVHD). Non-transplantation indications _Endogenous uveitis_ Treatment of sight-threatening intermediate or posterior uveitis of non-infectious aetiology in patients in whom conventional therapy has failed or c 阅读完整的文件