Страна: Малайзия
Език: английски
Източник: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
CYCLOSPORIN A
NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.
CYCLOSPORIN A
50Capsule Capsules
Catalent Germany Eberbach GmbH
_Consumer Medication Information Leaflet (RiMUP)_ SANDIMMUN NEORAL ® Ciclosporin (25 mg, 100 mg Soft Gelatin Capsule & 100mg/mL Oral Solution) 1 WHAT IS IN THIS LEAFLET 1. What Sandimmun Neoral is used for 2. How Sandimmun Neoral works 3. Before you use Sandimmun Neoral 4. How to use Sandimmun Neoral 5. While you are using Sandimmun Neoral 6. Side effects 7. Storage and Disposal of Sandimmun Neoral 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT SANDIMMUN NEORAL IS USED FOR The name of your medicine is Sandimmun Neoral and it contains the active substance ciclosporin. It is one of a group of medicines known as immunosuppressive agents. These medicines are used to diminish the body’s immune reactions. HOW SANDIMMUN NEORAL WORKS If you have received a graft transplant the function of Sandimmun Neoral is to control your body’s immune system. Sandimmun Neoral prevents rejection of transplanted organs by blocking the development of special cells which would normally attack the transplanted tissue. If you suffer from a non-transplant disease where your body’s own immune response attacks the cells in your body (autoimmune diseases), Sandimmun Neoral suppresses immunoreactions in those diseases. Such autoimmune diseases are vision-threatening eye disease (intermediary or posterior uveitis and Behçet's uveitis), severe cases of certain skin diseases (psoriasis), severe rheumatoid arthritis and a kidney disease, called nephrotic syndrome. BEFORE YOU USE SANDIMMUN NEORAL If you are receiving Sandimmun Neoral for transplantation, it will only be prescribed for you by a doctor with experience in transplantation medicine. You will notice that the advice contained in this leaflet may vary depending on whether you are receiving this medicine for transplantation or taking it for your autoimmune disease. Follow all the doctor’s instructions carefully. They may differ from the general information contained in this leaflet. _ _ _ _ _ _ _When you must not use it _ If you are Прочетете целия документ
Novartis Page 2 Malaysian Package Leaflet 18-Jul-2022 Sandimmun Neoral SANDIMMUN NEORAL SANDIMMUN Immunosuppressive agents, calcineurin inhibitors DESCRIPTION AND COMPOSITION PHARMACEUTICAL FORMS SANDIMMUN NEORAL SOFT-GELATIN CAPSULES. 25 mg: blue-grey oval shaped gelatin capsule, soft, imprinted with “NVR 25mg” in red 100 mg: blue-grey oblong shaped gelatin capsule, soft, imprinted with “NVR 100mg” in red SANDIMMUN NEORAL ORAL SOLUTION: clear, faintly yellow to browning yellow solution for oral administration. The formulation of Sandimmun Neoral is a microemulsion preconcentrate. SANDIMMUN CONCENTRATE FOR SOLUTION FOR INFUSION: clear, brown-yellow, oleaginous concentrate to be diluted before parenteral administration. ACTIVE SUBSTANCE Each capsule contains 25 or 100 mg of ciclosporin. The oral solution contains 100 mg of ciclosporin per mL. Each bottle of 50 mL contains 5000 mg of ciclosporin. Sandimmun Neoral is a pharmaceutical form of the active ingredient ciclosporin based on the microemulsion principle, which reduces the variability of pharmacokinetic parameters and provides dose linearity of ciclosporin exposure with a more consistent absorption profile and less influence from concomitant food intake. The Sandimmun Neoral formulation is a microemulsion preconcentrate, which in pharmacokinetic and clinical studies has demonstrated that the correlation between trough concentration and exposure to ciclosporin is much stronger when ciclosporin is given as Sandimmun Neoral than when it is given as Sandimmun. The formation of the microemulsion itself takes place in the presence of water, either in the form of a beverage or in the form of the gastric fluid. The concentrate for solution for infusion contains 50 mg per mL. Each ampoule of 1 mL contains 50 mg of ciclosporin. Each ampoule of 5 mL contains 250 mg of ciclosporin. Certain dosage strengths and dosage forms may not be available in all countries. EXCIPIENTS SOFT GELATIN CAPSULES Capsule content: alpha–tocopherol, ethanol anhydrous, propyl Прочетете целия документ