Země: Austrálie
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
rasagiline mesilate, Quantity: 1.56 mg (Equivalent: rasagiline, Qty 1 mg)
Generic Health Pty Ltd
Tablet
Excipient Ingredients: maize starch; purified talc; stearic acid; microcrystalline cellulose; pregelatinised maize starch; citric acid monohydrate; colloidal anhydrous silica
Oral
10 tablets, 30 tablets
(S4) Prescription Only Medicine
Rasagiline is indicated for the symptomatic treatment of idiopathic Parkinson?s disease (PD) as monotherapy and as adjunct therapy to dopamine agonists or to levodopa.
Visual Identification: White to off-white, circular, flat faced, beveled edge, uncoated tablets, "1" debossed on one face with the other face plain.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2018-09-13
CONSUMER MEDICINE INFORMATION RASAZIL (RASAGILINE MESILATE) TABLETS WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Rasazil. 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 Rasazil 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 RASAZIL IS USED FOR Rasazil is used to treat the symptoms of Parkinson’s disease. It can be taken with or without dopamine agonist or levodopa therapy. Parkinson’s disease is a condition of the brain that mainly affects body movement. The three main symptoms of Parkinson’s disease are: • shaking (tremor); • muscle stiffness; and • slow and unsteady movement. In Parkinson’s disease, there is a loss of cells producing dopamine in certain areas in the brain. Rasazil works by increasing and maintaining the level of dopamine in your brain which will decrease 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 available only with a doctor’s prescription. It is not addictive. Rasazil should not be given to children under 18 years of age as there is no specific information about such use. Always ask your doctor before giving medicines to children. BEFORE YOU TAKE RASAZIL _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE RASAZIL IF YOU HAVE EVER HAD AN ALLERGIC REACTION TO RASAGILINE OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. If you have an allergic reaction you may get a skin rash, have difficulty in breathing, get symptoms of hay fever or feel faint. IF YOU ARE ALREADY TAKING RASAZIL, DO NOT TAKE ANOTHER MEDICINE CALLED: • MONOAMINE OXIDASE INHIBITORS (MAOI), WHETHER USED TO TREAT Přečtěte si celý dokument
AUSTRALIAN PRODUCT INFORMATION – RASAZIL (RASAGILINE MESILATE) TABLETS 1 NAME OF THE MEDICINE Rasagiline mesilate. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 1 mg rasagiline (as mesilate). For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM White to off-white, circular, flat faced, beveled edge, uncoated tablets, “1” debossed on one face with the other face plain. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Rasagiline is indicated for the symptomatic treatment of idiopathic Parkinson’s Disease (PD) as monotherapy and as adjunct therapy to dopamine agonists or to levodopa. 4.2 DOSE AND METHOD OF ADMINISTRATION Rasagiline should be administered orally, at a dose of 1 mg once daily in both monotherapy and adjunct therapy. It may be taken with or without food. Clinical trials have demonstrated no efficacy advantage for higher doses of rasagiline. Change of levodopa dose in adjunct therapy: When rasagiline is used in combination with levodopa, a reduction of the levodopa dosage may be considered based upon individual response. ELDERLY PATIENTS (>65 YEARS) No change in dosage is required for elderly patients. Rasagiline was shown to be well-tolerated in elderly PD patients in both monotherapy and adjunct therapy. CHILDREN AND ADOLESCENTS (<18 YEARS) Not recommended as the safety and efficacy have not been established in this population. PATIENTS WITH HEPATIC IMPAIRMENT Rasagiline should not be used in patients with hepatic insufficiency (see SECTION 4.3 CONTRAINDICATIONS). Rasazil v3.0 Page 2 of 23 (rasagiline mesilate) tablets PATIENTS WITH RENAL IMPAIRMENT No change in dosage is required for moderate renal impairment. 4.3 CONTRAINDICATIONS Rasagiline is contraindicated for use in patients who have demonstrated hypersensitivity to rasagiline or tablet excipients. Concomitant treatment with monoamine oxidase inhibitors (MAOIs) should be avoided (see SECTION 4.5 INTERACTIONS WITH OTHER MEDICINES AND OTHER FORMS OF INTERACTIONS). At least 14 days Přečtěte si celý dokument