Land: Australien
Sprog: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
Leflunomide
Apotex Pty Ltd
Medicine Registered
APO-LEFLUNOMIDE TABLETS _Contains the active ingredient leflunomide_ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_ WHAT IS IN THIS LEAFLET READ THIS LEAFLET CAREFULLY BEFORE TAKING YOUR MEDICINE. This leaflet answers some common questions about leflunomide. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. The information in this leaflet was last updated on the date listed on the last page. More recent information on this medicine may be available. ASK YOUR DOCTOR OR PHARMACIST: • if there is anything you do not understand in this leaflet, • if you are worried about taking your medicine, or • to obtain the most up-to-date information. You can also download the most up to date leaflet from www.apotex.com.au. All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you. Pharmaceutical companies cannot give you medical advice or an individual diagnosis. Keep this leaflet with your medicine. You may want to read it again. WHAT THIS MEDICINE IS USED FOR The name of your medicine is APO- Leflunomide. It contains the active ingredient leflunomide. It is used to treat: • rheumatoid arthritis Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed this medicine for another reason. This medicine is available only with a doctor's prescription. _HOW IT WORKS_ Leflunomide belongs to a group of medicines called disease-modifying anti-rheumatic drugs (DMARDs), which act to decrease joint damage and disability due to rheumatoid arthritis. In rheumatoid arthritis, leflunomide works by reducing the activity of the immune system, which helps to reduce inflammation, swelling and pain in affected joints. It also helps to reduce damage to those joints. There is no evidence that this medicine is addictive. _USE IN CHILDREN_ There is not enou Læs hele dokumentet
Product Information – Australia APO-Leflunomide Tablets Page 1 APO-LEFLUNOMIDE TABLETS NAME OF THE MEDICINE Leflunomide. Chemical Name: _N_-(4-trifluoromethylphenyl)-5-methylisoxazol-4-carboxamide) Chemical Structure: Molecular Formula: C 12 H 9 F 3 N 2 O 2 Molecular Weight: 270.2 CAS Registry Number: 75706-12-6 DESCRIPTION Leflunomide is a white to off white powder, practically insoluble in water and freely soluble in ethanol or acetone. 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 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 anti-proliferative 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 radio-labelled 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, pyrimidine synthesis in lymphocytes and other rapidly dividing cell populations may be inhibited. Further, the inhibition of tyrosine kinase activity has been reported, for both _in vitro_ and _in vivo_ situations. The _in vitro_ activity does not seem to be mediated directly through enzyme inhibition and takes place only at much higher concentration Læs hele dokumentet