País: Reino Unido
Idioma: inglés
Fuente: MHRA (Medicines & Healthcare Products Regulatory Agency)
Siltuximab
Janssen-Cilag Ltd
L04AC11
Siltuximab
100mg
Powder for solution for infusion
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: 08020400; GTIN: 5012674902592
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT SYLVANT 100 mg powder for concentrate for solution for infusion siltuximab 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 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, pharmacist, or nurse. - 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 SYLVANT is and what it is used for 2. What you need to know before you are given SYLVANT 3. How SYLVANT is given 4. Possible side effects 5. How to store SYLVANT 6. Contents of the pack and other information 1. WHAT SYLVANT IS AND WHAT IT IS USED FOR WHAT SYLVANT IS SYLVANT is a medicine that contains the active substance siltuximab. Siltuximab is a monoclonal antibody (a specialised type of protein) that binds selectively to an antigen (a target protein) in the body called interleukin-6 (IL-6). WHAT SYLVANT IS USED FOR SYLVANT is used to treat multicentric Castleman’s disease (MCD) in adult patients who do not have human immunodeficiency virus (HIV) or human herpesvirus-8 (HHV-8) infection. Multicentric Castleman’s disease causes benign tumours (non-cancerous growths) to develop in the lymph nodes in the body. Symptoms of this disease may include feeling tired, sweating at night, having a tingling feeling, and loss of appetite. HOW SYLVANT WORKS Patients with MCD produce too much IL-6 and this is thought to contribute to the abnormal growth of certain cells in lymph nodes. By binding to IL-6, siltuximab blocks its activity and stops abnormal cell growth. This helps reduce the size of the affected lymph nodes, which reduces the symp Leer el documento completo
OBJECT 1 SYLVANT 100 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION Summary of Product Characteristics Updated 24-May-2018 | Janssen-Cilag 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 SYLVANT 100 mg powder for concentrate for solution for infusion SYLVANT 400 mg powder for concentrate for solution for infusion 2. Qualitative and quantitative composition SYLVANT 100 mg powder for concentrate for solution for infusion Each single-use vial contains 100 mg siltuximab powder for concentrate for solution for infusion. After reconstitution the solution contains 20 mg siltuximab per mL. SYLVANT 400 mg powder for concentrate for solution for infusion Each single-use vial contains 400 mg siltuximab powder for concentrate for solution for infusion. After reconstitution the solution contains 20 mg siltuximab per mL. Siltuximab is a chimeric (human-murine) immunoglobulin G1κ (IgG1κ) monoclonal antibody produced in a Chinese hamster ovary (CHO) cell line by recombinant DNA technology. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Powder for concentrate for solution for infusion. The product is a freeze-dried white powder. 4. Clinical particulars 4.1 Therapeutic indications SYLVANT is indicated for the treatment of adult patients with multicentric Castleman's disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative. 4.2 Posology and method of administration This medicinal product should be administered by qualified healthcare professionals and under appropriate medical supervision. Posology The recommended dose is 11 mg/kg siltuximab given over 1 hour as an intravenous infusion administered every 3 weeks until treatment failure. _Treatment criteria_ Haematology laboratory tests should be performed prior Leer el documento completo