Valsts: Austrālija
Valoda: angļu
Klimata pārmaiņas: Department of Health (Therapeutic Goods Administration)
dimethyl fumarate, Quantity: 120 mg
Pharmacor Pty Ltd
Capsule, enteric
Excipient Ingredients: silicified microcrystalline cellulose; triethyl citrate; croscarmellose sodium; magnesium stearate; purified talc; methacrylic acid copolymer; colloidal anhydrous silica; titanium dioxide; indigo carmine; purified water; iron oxide yellow; Gelatin; polysorbate 80; sodium lauryl sulfate
Oral
112's, 70's, 14's
(S4) Prescription Only Medicine
It is indicated in patients with relapsing multiple sclerosis to reduce the frequency of relapses and to delay the progression of disability.
Visual Identification: White to off white, enteric coated round shaped mini tablets filled in size "1" hard gelatin capsule, opaque green cap printed with "DMF" and opaque white body printed with "120" in black ink.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 30 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2021-07-14
Akm Dimethyl Fumarate (Version-02) Page 1 AKM DIMETHYL FUMARATE _ DIMETHYL FUMARATE _ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Akm Dimethyl Fumarate. 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. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Akm Dimethyl fumarate 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 AKM DIMETHYL FUMARATE IS USED FOR Akm Dimethyl Fumarate is used to treat relapsing multiple sclerosis (MS). Akm Dimethyl Fumarate 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 Akm Dimethyl Fumarate. However Akm Dimethyl Fumarate cannot repair damage that has already been caused by MS. When you start Akm Dimethyl Fumarate you might not notice an improvement, but Akm Dimethyl Fumarate 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'. Akm Dimethyl Fumarate contains the active ingredient dimethyl fumarate. Dimethyl fumarate decreases the inflammation in your brain that is cau Izlasiet visu dokumentu
Akm Dimethyl Fumarate (Version-02) Page 1 AUSTRALIAN PRODUCT INFORMATION AKM DIMETHYL FUMARATE (DIMETHYL FUMARATE) DELAYED RELEASE CAPSULES 1. NAME OF THE MEDICINE Dimethyl fumarate 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Akm Dimethyl Fumarate 120 mg Delayed Release Capsules Each capsule contains 120 mg of Dimethyl fumarate Akm Dimethyl Fumarate 240 mg Delayed Release Capsules Each capsule contains 240 mg of Dimethyl fumarate For the full list of excipients, see section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Capsule, Delayed release Akm Dimethyl Fumarate 120 mg Delayed Release Capsules- White to off white, enteric coated round shaped mini tablets filled in size "1" hard gelatin capsules, Opaque Green cap printed with "DMF" and Opaque white body printed with" 120" in black ink. Akm Dimethyl Fumarate 240 mg Delayed Release Capsules- White to off white, enteric coated round shaped mini tablets filled in size "0" hard gelatin capsules, Opaque Green cap printed with "DMF" and Opaque green body printed with "240" in black ink. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Akm Dimethyl Fumarate is indicated in patients with relapsing multiple sclerosis to reduce the frequency of relapses and to delay the progression of disability. 4.2 DOSE AND METHOD OF ADMINISTRATION The starting dose for Akm Dimethyl Fumarate is 120 mg twice a day orally. After 7 days, increase to the recommended dose of 240 mg twice a day orally. Akm Dimethyl Fumarate (Version-02) Page 2 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. Akm Dimethyl Fumarate can be taken with or without food. For those patients who may experience gastrointestinal or flushing side effects, taking Akm Dimethyl Fumarate with food may improve tol Izlasiet visu dokumentu