国: イギリス
言語: 英語
ソース: MHRA (Medicines & Healthcare Products Regulatory Agency)
Infliximab
Pfizer Ltd
L04AB02
Infliximab
100mg
Powder for solution for infusion
Intravenous
No Controlled Drug Status
VMP not recommended to prescribe - brands not bioequivalent
BNF: 10010300; GTIN: 5015997108528
Page 1 of 13 B. PACKAGE LEAFLET Page 2 of 13 PACKAGE LEAFLET: INFORMATION FOR THE USER INFLECTRA 100 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION Infliximab 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. Your doctor will also give you a Patient Alert Card, which contains important safety information you need to be aware of before and during your treatment with Inflectra. If you have any further questions, ask your doctor. 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. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Inflectra is and what it is used for 2. What you need to know before you use Inflectra 3. How Inflectra will be given 4. Possible side effects 5. How to store Inflectra 6. Contents of the pack and other information 1. WHAT INFLECTRA IS AND WHAT IT IS USED FOR Inflectra contains the active substance called infliximab. Infliximab is a type of protein of human and mouse origin. Inflectra belongs to a group of medicines called ‘TNF blockers’. It is used in adults for the following inflammatory diseases: Rheumatoid arthritis Psoriatic arthritis Ankylosing spondylitis (Bechterew’s disease) Psoriasis. Inflectra is also used in adults and children 6 years of age or older for: Crohn’s disease Ulcerative colitis. Inflectra works by blocking the action of a protein called ‘tumour necrosis factor alpha’ (TNF α ). This protein is involved in inflammatory processes of the body and blocking i 完全なドキュメントを読む
OBJECT 1 INFLECTRA 100 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION Summary of Product Characteristics Updated 06-Mar-2018 | Hospira 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 Inflectra 100 mg powder for concentrate for solution for infusion 2. Qualitative and quantitative composition One vial contains 100 mg of infliximab*. After reconstitution each mL contains 10 mg of infliximab. * Infliximab is a chimeric human-murine IgG1 monoclonal antibody produced in murine hybridoma cells 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 powder is white. 4. Clinical particulars 4.1 Therapeutic indications Rheumatoid arthritis Inflectra, in combination with methotrexate, is indicated for the reduction of signs and symptoms as well as the improvement in physical function in: • adult patients with active disease when the response to disease-modifying antirheumatic drugs (DMARDs), including methotrexate, has been inadequate. • adult patients with severe, active and progressive disease not previously treated with methotrexate or other DMARDs. In these patient populations, a reduction in the rate of the progression of joint damage, as measured by X- ray, has been demonstrated (see section 5.1). Adult Crohn's disease Inflectra is indicated for: • treatment of moderately to severely active Crohn's disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. • treatment of fistulising, active Crohn's disease, in adult patients who have not responded despite a full and adequate course of therapy with c 完全なドキュメントを読む