מדינה: אוסטרליה
שפה: אנגלית
מקור: Department of Health (Therapeutic Goods Administration)
teriflunomide, Quantity: 14 mg
Dr Reddys Laboratories Australia Pty Ltd
Tablet
Excipient Ingredients: maize starch; magnesium stearate; hyprolose; silicon dioxide; lactose monohydrate; sodium starch glycollate; titanium dioxide; hypromellose; iron oxide yellow; macrogol 6000; indigo carmine aluminium lake
Oral
5, 84, 28, 10, 14
(S4) Prescription Only Medicine
TERIFLUNOMIDE DR.REDDY'S is indicated for the treatment of patients with relapsing forms of Multiple Sclerosis to reduce the frequency of clinical relapses and to delay the progression of physical disability.
Visual Identification: Blue coloured, pentagonal shaped, biconvex, film coated tablets, debossed with "14" on one side and "T" on other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2019-04-08
TERIFLUNOMIDE DR.REDDY ’ S _Teriflunomide_ _ _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Teriflunomide Dr.Reddy’s. 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 Dr.Reddy’s 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 DR.REDDY’S IS USED FOR Teriflunomide Dr.Reddy’s 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 Dr.Reddy’s 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 Dr.Reddy’s has been shown to reduce or decrease the number of relapses and slow down the progression of physical disability in patients with relapsing forms of MS. Although it is not a cure, patients treated with Teriflunomide Dr.Reddy’s generally find they will have fewer relapses. Your doctor, however, may have prescribed Teriflunomide Dr.Reddy’s 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 T קרא את המסמך השלם
PRODUCT INFORMATION TERIFLUNOMIDE DR.REDDY’S (TERIFLUNOMIDE) 1 NAME OF THE MEDICINE Teriflunomide 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 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 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. Excipients with known effect: Each tablet contains 83.4 mg of lactose monohydrate. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM TERIFLUNOMIDE DR.REDDY’S is available as a blue coloured, pentagonal shaped, biconvex film-coated tablet with “14” debossed on one side and “T” on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS TERIFLUNOMIDE DR.REDDY’S is indicated for the treatment of patients with relapsing forms of Multiple Sclerosis to reduce the frequency of clinical relapses and to delay the progression of physical disability. Page 1 4.2 DOSE AND METHOD OF ADMINISTRATION The recommended dose of TERIFLUNOMIDE DR.REDDY’S is 14mg orally once daily. TERIFLUNOMIDE DR.REDDY’S can be taken with or without food. SPECIAL POPULATIONS _CHILDREN_ _ _ The safety and efficacy of teriflunomide in paediatric patients with MS below the age of 18 years has not yet been established. _ELDERLY_ _ _ Clinical studies of teriflunomide did not include patients over 65 years old. TERIFLUNOMIDE DR.REDDY’S should be used with caution in patients aged over 65 years. _HEPATIC IMPAIRMENT_ _ _ No dosage adjustment is necessary for patients with mild or moderate hepatic impairment. Teriflun קרא את המסמך השלם