Negara: Australia
Bahasa: Inggris
Sumber: Department of Health (Therapeutic Goods Administration)
levodopa, Quantity: 125 mg; entacapone, Quantity: 200 mg; carbidopa monohydrate, Quantity: 33.8 mg (Equivalent: carbidopa, Qty 31.25 mg)
Sandoz Pty Ltd
carbidopa,Entacapone,Levodopa
Tablet, film coated
Excipient Ingredients: croscarmellose sodium; magnesium stearate; maize starch; mannitol; povidone; glycerol; hypromellose; polysorbate 80; iron oxide red; sucrose; titanium dioxide
Oral
10 Tablets, 30 tablets, 100 tablets
(S4) Prescription Only Medicine
Stalevo is indicated for the management of patients with Parkinson's disease who are experiencing motor fluctuations.
Visual Identification: Light brownish-red, oval tablets marked with 'LCE 125' on one side; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Licence status A
2009-12-16
STALEVO ® 1 STALEVO ® _Levodopa/carbidopa anhydrous/entacapone _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Stalevo. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. The information in this leaflet was last updated on the date listed on the final page. More recent information on the medicine may be available. YOU SHOULD ENSURE THAT YOU SPEAK TO YOUR PHARMACIST OR DOCTOR TO OBTAIN THE MOST UP TO DATE INFORMATION ON THE MEDICINE. YOU CAN ALSO DOWNLOAD THE MOST UP TO DATE LEAFLET FROM WWW.NOVARTIS.COM.AU. Those updates may contain important information about the medicine and its use of which you should be aware. All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine against the benefits they expect it will provide. IF YOU HAVE ANY CONCERNS ABOUT THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT STALEVO IS USED FOR Stalevo is used to treat the symptoms of Parkinson's disease. Parkinson's disease is a disorder of the nervous system. It is caused by a lack of dopamine, a natural substance that is produced in the brain. Dopamine relays messages in the part of the brain that controls muscle movement. When too little dopamine is produced, problems with movement result. Stalevo contains three active ingredients: levodopa, carbidopa anhydrous and entacapone. Levodopa is a chemical closely related to dopamine, which allows the body to make its own dopamine. Levodopa works by increasing the level of dopamine in the brain. Carbidopa makes sure that enough levodopa gets to the brain where it is needed, and entacapone makes the effect of levodopa last longer. Stalevo helps to relieve symptoms such as shaking of the limbs, stiffness and slowness of movement, which make it difficult to perform normal daily activities. Other medicines can also be added to help treat this condition. ASK YOU Baca dokumen lengkapnya
201105-stalevo-pi Page 1 of 21 AUSTRALIAN PRODUCT INFORMATION STALEVO (LEVODOPA/CARBIDOPA MONOHYDRATE/ENTACAPONE) FILM- COATED TABLETS 1. NAME OF THE MEDICINE Levodopa/carbidopa monohydrate/entacapone. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Stalevo film-coated tablets are available in six strengths, each containing a 4:1 ratio of levodopa to carbidopa monohydrate combined with 200 mg of entacapone in a standard release formulation: 50/12.5/200 mg, 75/18.75/200 mg, 100/25/200 mg, 125/31.25/200 mg, 150/37.5/200 mg and 200/50/200 mg. For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Stalevo 50 mg/12.5 mg/200 are round, biconvex tablets marked with ‘LCE 50’ on one side. Stalevo 75/18.75/200 are oval tablets marked with ‘LCE 75’ on one side. Stalevo 100/25/200 are oval tablets marked with ‘LCE 100’ on one side. Stalevo 125/31.25/200 are oval tablets marked with ‘LCE 125’ on one side. Stalevo 150/37.5/200 are elongated-ellipse shaped tablets marked with ‘LCE 150’ on one side. Stalevo 200/50/200 are oval tablets marked with ‘LCE 200’ on one side. Stalevo strengths 50/12.5/200 mg, 100/25/200 mg and 150/37.5/200 mg are brownish- or greyish-red, film-coated tablets. Stalevo strength 200/50/200 mg is a dark brownish-red film- coated tablet. Stalevo strengths 75/18.75/200 mg and 125/31.25/200 mg are light brownish red, film-coated tablets. 4. CLINICAL PARTICULARS 4.1. T HERAPEUTIC INDICATIONS Stalevo is indicated for the management of patients with Parkinson’s disease who are experiencing motor fluctuations. 4.2. D OSE AND METHOD OF ADMINISTRATION The optimum daily dosage of Stalevo must be determined by careful titration in each patient. The daily dose should preferably be optimised using one of the six available tablet strengths (50/12.5/200 mg, 75/18.75/200 mg, 100/25/200 mg, 125/31.25/200 mg, 150/37.5/200 mg, or 200/50/200 mg levodopa/carbidopa monohydrate/entacapone). Patients should be instructed to take only one Stalevo tablet per dose administra Baca dokumen lengkapnya