Land: Australien
Språk: engelska
Källa: Department of Health (Therapeutic Goods Administration)
leflunomide
Southern Cross Pharma Pty Ltd
Leflunomide
Registered
________________________________________________________________________________ C: Products/Leflunomide/CMI AN_15042014 Page 1 of 4 LEFLUNOMIDE AN TABLETS _leflunomide_ CONSUMER MEDICINE INFORMATION _ _ PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START LEFLUNOMIDE AN. What is in this leaflet This leaflet answers some common questions about Leflunomide AN. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Leflunomide AN against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. What Leflunomide AN is used for Leflunomide AN is a type of medicine used to treat rheumatoid or psoriatic arthritis. Leflunomide AN helps to slow down the process of joint damage and to relieve the symptoms of the disease, such as joint tenderness and swelling, pain and morning stiffness. Leflunomide AN works by selectively interfering with the ability of white blood cells called lymphocytes to produce the disease response that ultimately leads to pain, inflammation and joint damage. Your doctor, however, may have prescribed Leflunomide AN for another purpose. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY IT HAS BEEN PRESCRIBED FOR YOU. This medicine is only available with a doctor's prescription. Before you take it _When you must not take it _ DO NOT TAKE LEFLUNOMIDE AN IF YOU: HAVE ANY DISEASES WHICH REDUCE YOUR BODY'S NATURAL DEFENCES SUCH AS BACTERIAL OR VIRAL INFECTIONS HAVE ANY DISEASES OF THE BLOOD HAVE ANY SERIOUS SKIN DISORDERS HAVE LIVER DISEASE HAVE A CONDITION CALLED HYPOPROTEINAEMIA (WHEN YOU DO NOT HAVE ENOUGH PROTEIN IN YOUR BLOOD) ARE PREGNANT OR PLAN TO BECOME PREGNANT ARE NOT USING RELIABLE BIRTH CONTROL ARE BREASTFEEDING YOU MUST NOT BECOME PREGNANT WHILE TAKING LEFLUNOMIDE AN AN Läs hela dokumentet
C:Products/Leflunomide/PI AN_10082015 Page 1 of 30 PRODUCT INFORMATION LEFLUNOMIDE AN TABLETS NAME OF THE MEDICINE PROPRIETARY NAME: Leflunomide AN 10, 20 and 100 mg tablets NON PROPRIETARY NAME: Leflunomide tablets The chemical name for leflunomide is 5-methyl- _N_ -[4- (trifluoromethyl)phenyl]isoxazole-4- carboxamide, an isoxazole derivative. The chemical structure of leflunomide is: Molecular formula: C 12 H 9 F 3 N 2 O 2 MW: 270.2 CAS number: 75706-12-6 DESCRIPTION Leflunomide is a white to off white powder, practically insoluble in water and freely soluble in methanol, ethanol or acetone and sparingly soluble in methylene chloride. Leflunomide tablets also contain microcrystalline cellulose, lactose, maize starch, povidone, crospovidone, colloidal anhydrous silica and magnesium stearate. The 10 mg and 100 mg tablets contain the proprietary ingredient Opadry II complete film coating system OY LS 28908 White (ARTG 12435) and 20 mg tablet contains the proprietary ingredient Opadry aqueous film coating OY SR 6497 Yellow (ARTG 3965). PHARMACOLOGY _SITE AND MODE OF ACTION_ Leflunomide is an isoxazole immunomodulatory agent which is effective in animal models of arthritis and other autoimmune diseases, allergy and transplantation. In vivo, leflunomide is rapidly metabolised to the ring opened form, A771726, which is the active drug. It has immunomodulating / immunosuppressive characteristics, acts as an antiproliferative agent, and displays weak anti-inflammatory properties. The antiproliferative activity is reversed by the addition of uridine to the cell culture, indicating that A771726 acts at the level of the pyrimidine biosynthesis pathway. Binding studies using radiolabelled ligand demonstrate that the active metabolite binds to and inhibits the human enzyme dihydroorotate dehydrogenase (DHODH, an C:Products/Leflunomide/PI AN_10082015 Page 2 of 30 enzyme involved in de novo pyrimidine synthesis). Together, these data suggest that, in vivo, at concentrations achievable in patients receiving Leflunomide, pyrimid Läs hela dokumentet