Country: Միացյալ Թագավորություն
language: անգլերեն
source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ustekinumab
Janssen-Cilag Ltd
L04AC05
Ustekinumab
5mg/1ml
Solution for infusion
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: ; GTIN: 5012674902967
PACKAGE LEAFLET: INFORMATION FOR THE USER STELARA 130 MG CONCENTRATE FOR SOLUTION FOR INFUSION Ustekinumab READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. THIS LEAFLET HAS BEEN WRITTEN FOR THE PERSON TAKING THE MEDICINE. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Stelara is and what it is used for 2. What you need to know before you use Stelara 3. How Stelara will be given 4. Possible side effects 5. How to store Stelara 6. Contents of the pack and other information 1. WHAT STELARA IS AND WHAT IT IS USED FOR WHAT STELARA IS Stelara contains the active substance ‘ustekinumab’, a monoclonal antibody. Monoclonal antibodies are proteins that recognise and bind specifically to certain proteins in the body. Stelara belongs to a group of medicines called ‘immunosuppressants’. These medicines work by weakening part of the immune system. WHAT STELARA IS USED FOR Stelara is used to treat moderate to severe Crohn’s disease in adults. CROHN’S DISEASE Crohn’s disease is an inflammatory disease of the bowel. If you have Crohn’s disease you will first be given other medicines. If you do not respond well enough or are intolerant to these medicines, you may be given Stelara to reduce the signs and symptoms of your disease. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE STELARA DO NOT USE STELARA: IF YOU ARE ALLERGIC TO USTEKINUMAB or any of the other ingredients of this medicine (listed in section 6). IF YOU HAVE AN ACTIVE INFECTION which your doctor thinks is important. If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Stelara. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before using Stelara. Your doctor will check how read_full_document
OBJECT 1 STELARA 130 MG CONCENTRATE FOR SOLUTION FOR INFUSION Summary of Product Characteristics Updated 22-Mar-2018 | Janssen-Cilag Ltd 1. Name of the medicinal product STELARA 130 mg concentrate for solution for infusion 2. Qualitative and quantitative composition Each vial contains 130 mg ustekinumab in 26 mL (5 mg/mL). Ustekinumab is a fully human IgG1κ monoclonal antibody to interleukin (IL)-12/23 produced in a murine myeloma cell line using recombinant DNA technology. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Concentrate for solution for infusion. The solution is clear, colourless to light yellow. 4. Clinical particulars 4.1 Therapeutic indications Crohn's Disease STELARA is indicated for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNFα antagonist or have medical contraindications to such therapies. 4.2 Posology and method of administration STELARA concentrate for solution for infusion is intended for use under the guidance and supervision of physicians experienced in the diagnosis and treatment of Crohn's disease. STELARA concentrate for solution for infusion should only be used for the intravenous induction dose. Posology Crohn's Disease STELARA treatment is to be initiated with a single intravenous dose based on body weight. The infusion solution is to be composed of the number of vials of STELARA 130 mg as specified in Table 1 (see section 6.6 for preparation). _Table 1 Initial intravenous dosing of STELARA_ Body weight of patient at the time of dosing Recommended dose a Number of 130 mg STELARA Vials ≤ 55 kg 260 mg 2 > 55 kg to ≤ 85 kg 390 mg 3 > 85 kg 520 mg 4 a Approximately 6 mg/kg The first subcutaneous dose should be given at week 8 following the intravenous dose. For the posology of the subsequent subcutaneous dosing regimen, see section 4.2 of the STELARA solution for injection (vial) and solution for inject read_full_document