Țară: Regatul Unit
Limbă: engleză
Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)
Antithymocyte immunoglobulin (rabbit)
Sanofi
L04AA04
Antithymocyte immunoglobulin (rabbit)
25mg
Powder and solvent for solution for infusion
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: 08020200; GTIN: 5030045000111
MEASURE BAR SHOULD BE 150MM AT 100% SCALE Customer Description Item Code Profile Size Min. Point Size Market Language Proof By Proof No. Date Artwork No. Pharma Code Colours Used WARNING! We cannot accept responsibility for any errors in this proof after approval. Whilst we take extreme care at all times to ensure accuracy to our clientʼs brief, the final responsibility must be taken by our client. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT. Process Black Keyline (does not print) Genzyme UK (Suffolk) 624236 GI266305 266x305mm UK/ROI/MT English louise.heel 2 18/01/2016 626972 102x30mm 50 gsm THYMO 5MG/ML Leaflet 8.5pt Folded: N/A artwork.leicester@MULTIPKG.com CLEARLY MARK ANY AMENDMENTS ON ONE PROOF AND RETURN TO MPS PACKAGE LEAFLET: INFORMATION FOR THE USER POWDER FOR SOLUTION FOR INFUSION Rabbit anti-human thymocyte immunoglobulin 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. • This medicine will be given to you by a doctor or nurse in hospital. • If you have any further questions, ask your doctor or nurse. • If you get any side effects talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Thymoglobuline® is and what it is used for 2. What you need to know before you are given Thymoglobuline 3. How Thymoglobuline is given 4. Possible side effects 5. How to store Thymoglobuline 6. Contents of the pack and other information 1. WHAT THYMOGLOBULINE IS AND WHAT IT IS USED FOR Thymoglobuline belongs to a group of medicines called immunosuppressants (anti–rejection medicines). These medicines can help prevent the rejection of transplanted organs. They can also be used to treat other unwanted immune reactions. Thymoglobuline is made by injecting human thymus cells into rabbits. It contains immunoglobulins (antibodies) which attach to and destroy so Citiți documentul complet
OBJECT 1 THYMOGLOBULINE 25 MG POWDER FOR SOLUTION FOR INFUSION Summary of Product Characteristics Updated 03-Oct-2016 | SANOFI 1. Name of the medicinal product Thymoglobuline 25 mg powder for solution for infusion 2. Qualitative and quantitative composition Rabbit anti-human thymocyte immunoglobulin 25 mg per vial. 1 ml reconstituted solution contains 5 mg rabbit, anti-human thymocyte immunoglobulin. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Powder for solution for infusion 4. Clinical particulars 4.1 Therapeutic indications • Immunosuppression in solid organ transplantation - Prevention of graft rejection in renal transplantation - Treatment of steroid resistant graft rejection in renal transplantation - Prevention of graft rejection in heart transplantation. Thymoglobuline is usually used in combination with other immunosuppressive medicinal products. 4.2 Posology and method of administration Thymoglobuline must always be used under strict medical supervision and prescribed by physicians with experience in using immunosuppressive agents. Posology The posology depends on the indication, the administration regimen and the combination with other immunosuppressive agents. The following dosage may be used as a reference. Treatment can be discontinued without gradual tapering of the dose. _IMMUNOSUPPRESSION IN SOLID ORGAN TRANSPLANTATION _ Prophylaxis of graft rejection 1 to 1.5 mg/kg/day for 3 to 9 days after transplantation of a kidney, corresponding to a cumulative dose of 3 to 13.5 mg/kg. 1 to 2.5 mg/kg/day for 3 to 5 days after transplantation of a heart, corresponding to a cumulative dose of 3 to 12.5 mg/kg. Treatment of steroid resistant graft rejection: 1.5 mg/kg/day for 7 to 14 days after transplantation of a kidney, corresponding to a cumulative dose of 10.5 to 21 mg/kg. _Dose modifications_ For obese patients dosing should be based on ideal weight rather than actual weight. Special population _Paediatric Population_ Currently available data are described in section 4.8 and Citiți documentul complet