ประเทศ: ออสเตรเลีย
ภาษา: อังกฤษ
แหล่งที่มา: Department of Health (Therapeutic Goods Administration)
dimethyl fumarate, Quantity: 120 mg
Biogen Australia Pty Ltd
dimethyl fumarate
Capsule, modified release
Excipient Ingredients: colloidal anhydrous silica; Gelatin; methacrylic acid - ethyl acrylate copolymer (1:1); titanium dioxide; croscarmellose sodium; polysorbate 80; simethicone; methacrylic acid copolymer; magnesium stearate; brilliant blue FCF; microcrystalline cellulose; iron oxide yellow; triethyl citrate; sodium lauryl sulfate; purified talc; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide
Oral
14, 112
(S4) Prescription Only Medicine
TECFIDERA is indicated in patients with relapsing multiple sclerosis to reduce the frequency of relapses and to delay the progression of disability
Visual Identification: Size 0 hard-gelatin capsules, white body with green cap imprinted with "BG-12 120 mg" on body containing white to off-white enteric-coated microtablets.; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 48 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2013-07-11
TECFIDERA ® _Dimethyl fumarate_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about TECFIDERA. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. This leaflet was last updated on the date at the end of this leaflet. SPEAK TO YOUR PHARMACIST OR DOCTOR TO OBTAIN THE MOST UP TO DATE INFORMATION ON THIS MEDICINE. You can also download the most up to date leaflet from: www.biogen.com.au/products/ tecfidera-CMI.pdf All medicines have risks and benefits. Your doctor has weighed the risks of you taking TECFIDERA 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 TECFIDERA IS USED FOR TECFIDERA is used to treat relapsing multiple sclerosis (MS). TECFIDERA slows down the progression of physical disability in people with relapsing forms of MS and decreases the number of flare ups (relapses). Some people feel better when they start to take TECFIDERA. However TECFIDERA cannot repair damage that has already been caused by MS. When you start TECFIDERA you might not notice an improvement, but TECFIDERA may still be working to help prevent your MS from becoming worse. The cause of MS is not yet known, MS affects the brain and spinal cord. In MS, the body's immune system reacts against its own myelin (the 'insulation' surrounding nerve fibres). In relapsing forms of MS, people have 'exacerbations' from time to time (e.g. blurred vision, weakness in the legs or arms, or loss of control of bowel or bladder function). They are followed by periods of recovery. Recovery may be complete or incomplete. If it is incomplete there is 'progression of disability'. TECFIDERA contains the active ingredient dimethyl fumarate. Dimethyl fumarate decreases the inflammation in your brain that is caused by MS and thereby reduces nerve damage. TECFIDERA works by reducing infl อ่านเอกสารฉบับเต็ม
TECFIDERA PI (version 10621) 1 AUSTRALIAN PRODUCT INFORMATION TECFIDERA ® (DIMETHYL FUMARATE) MODIFIED RELEASE CAPSULES 1 NAME OF THE MEDICINE Dimethyl fumarate (DMF). 2 QUALITATIVE AND QUANTITATIVE COMPOSITION TECFIDERA (dimethyl fumarate [DMF]) is formulated as enteric coated microtablets enclosed within hard gelatin capsules, containing the active ingredient dimethyl fumarate. Each TECFIDERA capsule contains 120 mg or 240 mg DMF. The inactive ingredients of TECFIDERA are: microcrystalline cellulose, croscarmellose sodium, purified talc, colloidal anhydrous silica, magnesium stearate, triethyl citrate, methylacrylate-methyl methacrylate copolymer, methacrylic acid – ethyl acrylate copolymer (1:1), simethicone, sodium lauryl sulfate, polysorbate 80, gelatin, titanium dioxide, brilliant blue FCF (CI42090), iron oxide yellow (CI77492), iron oxide black (CI77499). 3 PHARMACEUTICAL FORM Modified release capsules. 120 mg capsules: TECFIDERA is supplied as green and white capsules printed with “BG-12 120 mg” in black ink on the capsule body. Each capsule contains 120 mg DMF. 240 mg capsules: TECFIDERA is supplied as green capsules printed with “BG-12 240 mg” in black ink on the capsule body. Each capsule contains 240 mg DMF. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS TECFIDERA is indicated in patients with relapsing multiple sclerosis to reduce the frequency of relapses and to delay the progression of disability. 4.2 D OSE AND METHOD OF ADMINISTRATION The starting dose for TECFIDERA is 120 mg twice a day orally. After 7 days, increase to the recommended dose of 240 mg twice a day orally. The capsule or its contents should not be crushed, divided or dissolved as the enteric coating of the microtablets prevents irritant effects on the gut. Temporary dose reduction to 120 mg twice a day may reduce the occurrence of flushing and gastrointestinal (GI) side effects. Within 1 month, the recommended dose of 240 mg twice a day orally should be resumed. TECFIDERA PI (version 10621) 2 TECFIDERA can be taken w อ่านเอกสารฉบับเต็ม