Kraj: Australia
Język: angielski
Źródło: Department of Health (Therapeutic Goods Administration)
Teriflunomide
Sanofi-Aventis Australia Pty Ltd
Medicine Registered
Consumer Medicines Information Teriflunomide Sanofi– teriflunomide 14 mg tablets Property of the sanofi-aventis group Teriflunomide Sanofi-ccdsv0-cmiv1-26oct12 Page 1 TERIFLUNOMIDE SANOFI ® _Teriflunomide _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Teriflunomide Sanofi. 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 Teriflunomide Sanofi 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 TERIFLUNOMIDE SANOFI IS USED FOR Teriflunomide Sanofi is used to treat relapsing forms of multiple sclerosis (MS). The cause of MS is not yet known. MS affects the central nervous system (CNS)– the brain and spinal cord. In MS, the body’s immune system reacts against its own myelin (the ‘insulation’ or the protective sheath surrounding nerve fibres). With relapsing forms of MS, people can have repeated attacks or relapses of inflammation of the CNS from time to time. Symptoms vary from patient to patient and may include blurred vision, weakness in the legs or arms, or loss of control of bowel or bladder function). These are followed by periods of recovery. Teriflunomide Sanofi works by selectively interfering with the ability of white blood cells (lymphocytes) to produce the disease response and nerve damage that ultimately leads to relapses. Teriflunomide Sanofi has been shown to reduce or decrease the number of relapses and slow down the progression of physical disa Przeczytaj cały dokument
Product Information November 2012 Teriflunomide Sanofi - teriflunomide 14 mg tablets Property of the sanofi-aventis group - strictly confidential sanofi-ccdsv0-piv1-26oct12.doc Page 1 PRODUCT INFORMATION TERIFLUNOMIDE SANOFI NAME OF THE MEDICINE AUSTRALIAN APPROVED NAME Teriflunomide CHEMICAL STRUCTURE The chemical structure of teriflunomide is F 3 C N O N H OH CH 3 Molecular formula: C 12 H 9 F 3 N 2 O 2 Molecular weight: 270.21 Chemical name: (Z)-2-Cyano-3-hydroxy-but-2-enoic acid-(4-trifluoromethylphenyl)-amide CAS REGISTRY NUMBER: 163451-81-8 DESCRIPTION Teriflunomide, is an oral _de novo_ pyrimidine synthesis inhibitor of the dihydroorotate dehydrogenase (DHO-DH) enzyme. Teriflunomide is a white to almost white powder that is sparingly soluble in acetone, slightly soluble in polyethylene glycol and ethanol, very slightly soluble in isopropanol and practically insoluble in water. Teriflunomide has a pKa of 3.1 at room temperature and its aqueous solubility Product Information November 2012 Teriflunomide Sanofi - teriflunomide 14 mg tablets Property of the sanofi-aventis group - strictly confidential sanofi-ccdsv0-piv1-26oct12.doc Page 2 is pH dependent and decreases with lowering pH. Teriflunomide is Class 2 in the Biopharmaceutics Classification System. Teriflunomide is formulated as film-coated tablets for oral administration. Each tablet contains 14 mg of teriflunomide and the following inactive ingredients: lactose, maize starch, hydroxypropylcellulose, microcrystalline cellulose, sodium starch glycollate, and magnesium stearate. The film coating (OPADRY complete film coating system 03F20651 BLUE) is made of hypromellose, titanium dioxide, purified talc, macrogol 8000 and indigo carmine aluminium lake. PHARMACOLOGY PHARMACODYNAMICS MECHANISM OF ACTION Teriflun Przeczytaj cały dokument