Država: Australija
Jezik: engleski
Izvor: Department of Health (Therapeutic Goods Administration)
teriflunomide, Quantity: 14 mg
Emcure Pharmaceuticals Pty Ltd
Tablet, film coated
Excipient Ingredients: hyprolose; maize starch; microcrystalline cellulose; sodium starch glycollate type A; silicon dioxide; lactose monohydrate; magnesium stearate; titanium dioxide; macrogol 8000; hypromellose; purified talc; indigo carmine aluminium lake
Oral
28 tablets
(S4) Prescription Only Medicine
Teriflunomide 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: Light blue colored, round, biconvex, film coated tablet, debossed with 'HP' on one side and '555' on other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2020-05-27
Teri-EM ® 1 TERI-EM ® _Teriflunomide _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Teri-EM. 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 Teri-EM 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 TERI-EM IS USED FOR Teri-EM 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. Teri-EM 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. Teri-EM 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 Teri- EM generally find they will have fewer relapses. Your doctor, however, may have prescribed Teri-EM 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 TERI-EM IF YOU: _ _ • have any diseases which reduce your body's natural defences • have any diseases of th Pročitajte cijeli dokument
1 AUSTRALIAN PRODUCT INFORMATION – TERI-EM (TERIFLUNOMIDE) 1 NAME OF THE MEDICINE Teriflunomide 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Teriflunomide is formulated as film-coated tablets for oral administration. Each tablet contains 14 mg of Teriflunomide Excipients with known effect: Each tablet contains 76 mg of lactose monohydrate. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Teri-EM is a light blue coloured, round, biconvex, film coated tablet, debossed with 'HP' on one side and '555' on other side. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Teriflunomide 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. 4.2 D OSE AND METHOD OF ADMINISTRATION The recommended dose of Teri-EM is 14 mg orally once daily. Teri-EM can be taken with or without food. SPECIAL POPULATIONS _CHILDREN _ The safety and efficacy of Teri-EM in paediatric patients with MS below the age of 18 years has not yet been established. _ELDERLY _ Clinical studies of Teri-EM did not include patients over 65 years old. Teri-EM 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. Teriflunomide is contraindicated in patients with severe hepatic impairment (see Section 4.4 Special warnings and precautions for use). _ _ 2 _RENAL IMPAIRMENT _ No dosage adjustment is necessary for patients with severe renal impairment (see Section 4.4 Special warnings and precautions for use – Renal impairment). _SWITCHING PATIENTS FROM OR TO OTHER DISEASE MODIFYING THERAPIES _ For recommendations related to switching patients from other disease modifying therapies to Teri- EM (see Section 4.4 Special warnings and precautions for use - Switching to or from Teri-EM and Plasma Monitoring). 4.3 C ONTRAINDICATIONS Teriflunomide must not be given to: - patients with hyper Pročitajte cijeli dokument