Šalis: Australija
kalba: anglų
Šaltinis: Department of Health (Therapeutic Goods Administration)
leflunomide, Quantity: 20 mg
Medis Pharma Pty Ltd
Leflunomide
Tablet, film coated
Excipient Ingredients: povidone; colloidal anhydrous silica; maize starch; microcrystalline cellulose; magnesium stearate; crospovidone; lactose monohydrate; titanium dioxide; hypromellose; purified talc; iron oxide yellow; macrogol 6000
Oral
30 Tablet
(S4) Prescription Only Medicine
Treatment of active rheumatoid arthritis. The combined use of leflunomide with other disease modifying antirheumatic drugs (DMARDs) has not been adequately studied (see Precautions). Lunava is not indicated for the treatment of psoriatic arthritis or psoriasis (whether or not associated with manifestations of psoriatic arthritis).
Visual Identification: Yellow, round biconvex tablets with a scoreline on one side; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Licence status A
2011-03-25
________________________________________________________________________________ Lunava CMI 270115 Page 1 of 4 LUNAVA ® TABLETS _leflunomide_ CONSUMER MEDICINE INFORMATION _ _ PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START LUNAVA. What is in this leaflet This leaflet answers some common questions about Lunava. 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 Lunava 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 Lunava is used for Lunava is a type of medicine used to treat rheumatoid arthritis. Lunava helps to slow down the process of joint damage and to relieve the symptoms of the disease, such as joint tenderness and swelling, pain and morning stiffness. Lunava works by selectively interfering with the ability of white blood cells called lymphocytes to produce the disease response that ultimately leads to pain, inflammation and joint damage. Your doctor, however, may have prescribed Lunava for another purpose. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY IT HAS BEEN PRESCRIBED FOR YOU. This medicine is only available with a doctor's prescription. Before you take it _When you must not take it _ DO NOT TAKE LUNAVA IF YOU: HAVE ANY DISEASES WHICH REDUCE YOUR BODY'S NATURAL DEFENCES SUCH AS BACTERIAL OR VIRAL INFECTIONS HAVE ANY DISEASES OF THE BLOOD HAVE ANY SERIOUS SKIN DISORDERS HAVE LIVER DISEASE HAVE A CONDITION CALLED HYPOPROTEINAEMIA (WHEN YOU DO NOT HAVE ENOUGH PROTEIN IN YOUR BLOOD) ARE PREGNANT OR PLAN TO BECOME PREGNANT ARE NOT USING RELIABLE BIRTH CONTROL ARE BREASTFEEDING YOU MUST NOT BECOME PREGNANT WHILE TAKING LUNAVA AND FOR A CERTAIN PERIOD OF TIME AFTER STOPPING LUNAVA. Lunava may increase the risk of birth defects. WOMEN OF CHILDBEARI Perskaitykite visą dokumentą
AUSTRALIAN PRODUCT INFORMATION - LUNAVA ® (LEFLUNOMIDE) TABLETS 1. NAME OF THE MEDICINE Leflunomide 2. QUANTITATIVE AND QUALITATIVE COMPOSITION Lunava 10 mg, 20 mg and 100 mg tablets contain the active ingredient leflunomide. For the full list of excipients, see Section 6.1 List of Excipients. Excipients with known effect: Contains sugars as lactose. 3. PHARMACEUTICAL FORM Lunava 10 mg tablets: white, round biconvex, film coated tablets. Lunava 20mg tablets: yellow, round biconvex tablets with a scoreline on one side Lunava 100mg tablets: white, oblong biconvex tablets with a scoreline on one side 4. CLINICAL PARTICULARS THERAPEUTIC INDICATIONS Treatment of active rheumatoid arthritis. The combined use of leflunomide with other disease modifying antirheumatic drugs (DMARDs) has not been adequately studied (see Section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE). Lunava is not indicated for the treatment of psoriatic arthritis or psoriasis (whether or not associated with manifestations of psoriatic arthritis). DOSE AND METHOD OF ADMINISTRATION RHEUMATOID ARTHRITIS _LOADING DOSE _ Leflunomide therapy is started with a loading dose of 100 mg once daily for three days. Avoiding a loading dose may decrease the risk of adverse events if leflunomide is used in combination with methotrexate. This could be especially important for patients at increased risk of haematological or hepatic toxicity, e.g. those receiving concomitant treatment with methotrexate or other immunosuppressive agents or on such medications in the recent past. (See Section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE, Concomitant use with hepatotoxic and haematotoxic agents, and Hepatotoxicity.) _MAINTENANCE DOSE _ The recommended maintenance dose for rheumatoid arthritis is leflunomide 20 mg once daily. Doses higher than 20 mg/day are not recommended. If dosing at 20 mg/day is not well tolerated, the dose may be decreased to 10 mg daily. Liver enzymes and haematological parameters must be monitored and dose adjustments or discontinuation may be ne Perskaitykite visą dokumentą