国家: 澳大利亚
语言: 英文
来源: Department of Health (Therapeutic Goods Administration)
rasagiline mesilate, Quantity: 1.56 mg (Equivalent: rasagiline, Qty 1 mg)
Teva Pharma Australia Pty Ltd
Tablet
Excipient Ingredients: stearic acid; purified talc; mannitol; colloidal anhydrous silica; maize starch; pregelatinised maize starch
Oral
10, 30
(S4) Prescription Only Medicine
RASALECT 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, round, flat, bevelled tablets, debossed with GIL + 1 on one side and plain on the other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2019-07-30
RASALECT™ R A S A L E C T C o n s u m e r M e d i c i n e I n f o r m a t i o n - V e r s i o n 2 CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING RASALECT? RASALECT contains the active ingredient rasagiline (as mesilate). RASALECT is used to treat the symptoms of Parkinson’s disease. It can be taken with or without dopamine agonist or levodopa therapy. For more information, see Section 1. Why am I using RASALECT? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE RASALECT? Do not use if you have ever had an allergic reaction to rasagiline or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use RASALECT? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with RASALECT and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE RASALECT? • The usual dose for RASALECT is one tablet of 1 mg taken orally once a day. • Swallow the tablets whole with a full glass of water. • RASALECT can be taken with or without food. More instructions can be found in Section 4. How do I use RASALECT? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING RASALECT? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using RASALECT. • Tell your doctor if you notice any unusual skin lumps or moles which are new or have changed. THINGS YOU SHOULD NOT DO • Do not stop taking this medicine without first checking with your doctor. • Do not take RASALECT to treat any other complaints unless your doctor tells you to. • Do not give your medicine to anyone else, even if their symptoms seem similar to yours. DRIVING OR USING M 阅读完整的文件
Rasalect PI V2 Based on CCSI_752_03_03_17 Page 1 AUSTRALIAN PRODUCT INFORMATION – RASALECT™ (RASAGILINE) 1 NAME OF THE MEDICINE Rasagiline 1 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 1 mg rasagiline (as mesilate) Rasagiline mesilate is a white to off-white powder, freely soluble in water or ethanol and sparingly soluble in isopropanol. Dissociation Constant: pKa (R 2 NH 2 + /R 2 NH) = 7.4 Partition Coefficient (Log P): Octanol/Water pH 1.2 5.0 7.0 7.4 Log P -1.10 0.09 1.56 1.84 For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM White to off-white, round, flat, bevelled tablets, debossed with “GIL” and “1” underneath on one side and plain on the other. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS RASALECT 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 D OSE 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. Rasalect PI V2 Based on CCSI_752_03_03_17 Page 2 PATIENTS WITH HEPATIC IMPAIRMENT Rasagiline should not be used in patients with hepatic insufficiency (SEE SECTION 4.3). PATIENTS WITH RENAL IMPAIRMENT No change in dosage is required for moderate renal impairment. 4.3 C ONTRAINDICATIONS Rasagiline is contrai 阅读完整的文件