Country: Awstralja
Lingwa: Ingliż
Sors: Department of Health (Therapeutic Goods Administration)
Leflunomide
Sanofi-Aventis Australia Pty Ltd
Leflunomide
leflunomide-gh-ccdsv18-19-cmiv7-31jul14 1 LEFLUNOMIDE GH ® _leflunomide _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Leflunomide GH. It does not contain all 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 GH 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 GH IS USED FOR Leflunomide GH is a type of medicine used to treat rheumatoid or psoriatic arthritis. Leflunomide GH 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 GH 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 GH 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 GH 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 GH AND FOR A CERTAIN PERIOD OF TIME AFTER STOPPING LEFLUNOMIDE GH. Leflunomide GH may increase the risk of birth defects. WOMEN OF CHILDBEARING POTENTIAL MUST USE RELIABLE CONTRACEPTION WHILE Aqra d-dokument sħiħ
PRODUCT INFORMATION October 2015 Leflunomide GH leflunomide-gh--ccdsv20piv2-14oct15 Page 1 PRODUCT INFORMATION LEFLUNOMIDE GH NAME OF MEDICINE AUSTRALIAN APPROVED NAME Leflunomide CHEMICAL STRUCTURE Each tablet of Leflunomide GH contains 10 mg or 20 mg of leflunomide. The chemical structure of leflunomide is shown below: Molecular Formula: C 12 H 9 F 3 N 2 O 2 Molecular Weight: 270.2 Chemical Name: N-(4-trifluoromethylphenyl)-5-methylisoxazol-4-carboxamide), an isoxazole derivative CAS REGISTRY NUMBER 75706-12-6 DESCRIPTION Each tablet contains leflunomide, lactose, maize starch, povidone, colloidal anhydrous silica, magnesium stearate, crospovidone, hypromellose, macrogol 8000, talc and titanium dioxide. The 20mg tablets also contain iron oxide yellow. Leflunomide is a white to off white powder, practically insoluble in water and freely soluble in ethanol or acetone. PRODUCT INFORMATION October 2015 Leflunomide GH leflunomide-gh--ccdsv20piv2-14oct15 Page 2 PHARMACOLOGY PHARMACODYNAMICS MECHANISM 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 metabolized to the ring opened form, A771726, which is the active drug. It has immunomodulating/immunosuppressive characteristics, acts as an anti-proliferative 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 enzyme involved in de novo pyrimidine synthesis). Together, these data suggest that, in vivo, at concentrations achievable in patients receiving Leflunomide GH, pyrimidine synthesis in lymphocytes and other rapidly dividing cell populations may be inhibited. Further, the inhibition o Aqra d-dokument sħiħ