Maa: Australia
Kieli: englanti
Lähde: Department of Health (Therapeutic Goods Administration)
safinamide mesilate, Quantity: 65.88 mg (Equivalent: safinamide, Qty 50 mg)
Seqirus Pty Ltd
Tablet, film coated
Excipient Ingredients: crospovidone; magnesium stearate; colloidal anhydrous silica; microcrystalline cellulose; Colour; hypromellose; macrogol 6000
Oral
10 x Tablets, 30 x Tablets
(S4) Prescription Only Medicine
Xadago is indicated for the treatment of adult patients with fluctuating idiopathic Parkinson?s disease (PD) as add-on therapy to a regimen that includes levodopa (L-Dopa)
Visual Identification: Orange to copper, round, biconcave, immediate release, film-coated tablet (7mm in diameter) with metallic gloss and embossed with "50" on one side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 4 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2018-11-02
Xadago ® Consumer Medicine Information (CMI) Page 1 of 4 This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems. XADAGO ® (_Za-da-go_) _SAFINAMIDE_ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Xadago ® . It does not contain all of 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 Xadago ® against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. READ THIS LEAFLET CAREFULLY AND KEEP IT WITH THE MEDICINE. You may need to read it again. WHAT XADAGO ® IS USED FOR Xadago ® is used to treat Parkinson’s disease. It is taken when levodopa on its own (or with other medicines) does not control the symptoms of Parkinson’s Disease. Xadago ® belongs to a group of medicines called monoamine oxidase inhibitors (MAOIs). It contains an active ingredient called safinamide. Parkinson's disease is a condition of the brain that mainly affects movement. The three main symptoms of Parkinson's disease are: Shaking (tremor) Muscle stiffn ess Sl ow and unsteady moveme nt. The symptoms of Parkinson's disease are caused by a lack of dopamine. Dopamine is a natural substance that is made in the brain and helps with movement. Xadago ® works by increasing the level of dopamine in the brain. This decreases the symptoms of Parkinson's disease. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is only available with a doctor’s prescription. Xadago ® is not addictive. There is not enough information to recommend the use of this medi Lue koko asiakirja
XADAGO ® PRODUCT INFORMATION AUST R 292144 AND 292145 Page 1 of 23 ▼ This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at www.tga.gov.au/reporting-problems. AUSTRALIAN PRODUCT INFORMATION – XADAGO ® (SAFINAMIDE) 1 NAME OF THE MEDICINE Safinamide (as mesilate) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Xadago ® tablets contain 50 or 100 mg safinamide (as mesilate). For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM _XADAGO_ _®_ _ 50 MG TABLETS_: Orange to copper, round, biconcave, immediate release, film-coated tablets (7 mm diameter) with metallic gloss and “50” embossed on one side. Each tablet contains 50 mg safinamide (as mesilate). _XADAGO_ _®_ _ 100 MG TABLETS: _ Orange to copper, round, biconcave, immediate release, film- coated tablets (9 mm diameter) with metallic gloss and “100” embossed on one side. Each tablet contains 100 mg safinamide (as mesilate). 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Xadago ® is indicated for the treatment of adult patients with fluctuating idiopathic Parkinson’s disease (PD) as add-on therapy to a regimen that includes levodopa (L-Dopa). 4.2 DOSE AND METHOD OF ADMINISTRATION Xadago ® treatment should be started at 50 mg/day. The dose may be increased to 100 mg/day after two weeks on the basis of individual clinical need. XADAGO ® PRODUCT INFORMATION AUST R 292144 AND 292145 Page 2 of 23 Xadago ® tablets are for oral use. Xadago ® should be taken with water. Xadago ® may be taken with or without food. If a dose is missed, the next dose should be taken at the usual time the next day. _Discontinuation: _ Xadago ® 50 mg can be discontinued without down titration. Xadago ® 100 mg should be tapered by decreasing the dose to 50 mg for one week prior to discontinuation. PAEDIATRIC PATIENTS The safety and efficacy of safinamide in children and adolesce Lue koko asiakirja