Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Secukinumab
Novartis Pharmaceuticals UK Ltd
Secukinumab
150mg/1ml
Solution for injection
Subcutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 10010300; GTIN: 5010678903195
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT COSENTYX ® 150 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE Secukinumab This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, pharmacist or nurse. - 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Cosentyx is and what it is used for 2. What you need to know before you use Cosentyx 3. How to use Cosentyx 4. Possible side effects 5. How to store Cosentyx 6. Contents of the pack and other information 1. WHAT COSENTYX IS AND WHAT IT IS USED FOR Cosentyx contains the active substance secukinumab. Secukinumab is a monoclonal antibody. Monoclonal antibodies are proteins that recognise and bind specifically to certain proteins in the body. Cosentyx belongs to a group of medicines called interleukin (IL) inhibitors. This medicine works by neutralising the activity of a protein called IL-17A, which is present at increased levels in diseases such as psoriasis, psoriatic arthritis and ankylosing spondylitis. Cosentyx is used for the treatment of the following inflammatory diseases: Plaque psoriasis Psoriatic arthritis Ankylosing spondylitis PLAQUE PSORIASIS Cosentyx is used to treat a skin condition called “plaque psoriasis”, which causes inflammation affecting the skin. Cosentyx reduces the inflammation and other symptoms of the disease. Cosentyx is used in adults with moderate t Read the complete document
OBJECT 1 COSENTYX 150 MG SOLUTION FOR INJECTION IN PRE- FILLED PEN Summary of Product Characteristics Updated 17-May-2018 | Novartis Pharmaceuticals UK Ltd This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. Name of the medicinal product Cosentyx ® 150 mg solution for injection in pre-filled syringe Cosentyx ® 150 mg solution for injection in pre-filled pen 2. Qualitative and quantitative composition Each pre-filled syringe contains 150 mg secukinumab* in 1 ml. Each pre-filled pen contains 150 mg secukinumab* in 1 ml. *Secukinumab is a recombinant fully human monoclonal antibody selective for interleukin-17A. Secukinumab is of the IgG1/κ-class produced in Chinese Hamster Ovary (CHO) cells. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Solution for injection in pre-filled syringe (injection) Solution for injection in pre-filled pen (SensoReady pen) The solution is clear and colourless to slightly yellow. 4. Clinical particulars 4.1 Therapeutic indications Plaque psoriasis Cosentyx is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. Psoriatic arthritis Cosentyx, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate (see section 5.1). Ankylosing spondylitis Cosentyx is indicated for the treatment of active ankylosing spondylitis in adults who have responded inadequately to conventional therapy. 4.2 Posology and method of administration Cosentyx is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of conditions for which Cosentyx is indicated. Posology _Plaque psoriasis _ The recommen Read the complete document