Riik: Uus-Meremaa
keel: inglise
Allikas: Medsafe (Medicines Safety Authority)
Leflunomide 10mg
Apotex NZ Ltd
Leflunomide 10 mg
10 mg
Tablet
Active: Leflunomide 10mg Excipient: Colloidal silicon dioxide Crospovidone Lactose Magnesium stearate
Blister pack, Alu/Alu, 30 tablets, 30 tablets
Prescription
Prescription
Formosa Laboratories Inc.
Apo-Leflunomide is indicated for the treatment of: · Rheumatoid arthritis, to improve signs and symptoms to retard joint destruction and to improve functional ability and quality of life. Leflunomide may be used in patients who have failed to respond to other treatments or as a first line of treatment in patients who have a contraindication to other treatments. · Active Psoriatic Arthritis. Leflunomide is not indicated for the treatment of psoriasis that is not associated with manifestations of arthritic disease.
Package - Contents - Shelf Life: Blister pack, Alu/Alu, 30 tablets - 30 tablets - 24 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE, 30 tablets - 30 tablets - 24 months from date of manufacture stored at or below 25°C
2006-08-18
New Zealand Consumer Medicine Information APO-LEFLUNOMIDE _LEFLUNOMIDE _ 10mg and 20mg tablets WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start using Apo-Leflunomide. This leaflet answers some common questions about Apo-Leflunomide. 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 using Apo-Leflunomide against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. Keep this leaflet with the medicine. You may need to read it again. WHAT APO-LEFLUNOMIDE IS USED FOR The name of your medicine is Apo-Leflunomide tablet. It contains the active ingredient leflunomide. Apo-Leflunomide is a type of medicine used to treat: • rheumatoid arthritis or • psoriatic arthritis. Leflunomide 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. Leflunomide 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 may have prescribed Apo-Leflunomide for another reason. Ask your doctor if you have any questions about why Apo-Leflunomide has been prescribed for you. 2 This medicine is available only with a doctor's prescription. BEFORE YOU USE APO-LEFLUNOMIDE _ _ _WHEN YOU MUST NOT USE IT _ Do not use Apo-Leflunomide 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 Lugege kogu dokumenti
NEW ZEALAND DATA SHEET APO-LEFLUNOMIDE Please refer to Medsafe website (www.medsafe.govt.nz) for the most recent datasheet Page 1 of 26 1. APO-LEFLUNOMIDE (10MG AND 20MG TABLETS) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION LEFLUNOMIDE 10MG OR 20MG Chemical Structure: Leflunomide or N-(4-trifluoromethylphenyl)-5-methylisoxazol-4-carboxamide), an isoxazole derivative. Its empirical formula is C 12 H 9 F 3 N 2 O 2 The chemical structure of leflunomide is shown below: EXCIPIENT(S) WITH KNOWN EFFECT Apo-Leflunomide do not contain gluten. Apo-Leflunomide contain lactose For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM APO-LEFLUNOMIDE 10mg are white, round, biconvex tablet engraved "LE" over "10" on one side and "APO" on the other side. Each tablet typically weighs 70mg. APO-LEFLUNOMIDE 20mg are white, arc triangular shaped biconvex tablet, engraved "LE" over "20" on one side and "APO" on the other side. Each tablet typically weighs 140mg. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS APO-LEFLUNOMIDE is indicated for the treatment of: • Rheumatoid arthritis, to improve signs and symptoms to retard joint destruction and to improve functional ability and quality of life. Leflunomide may be used in patients who have failed to respond to other treatments or as a first line of treatment in patients who have a contraindication to other treatments. • Active Psoriatic Arthritis. Leflunomide is not indicated for the treatment of psoriasis that is not associated with manifestations of arthritic disease. 4.2 DOSE AND METHOD OF ADMINISTRATION LOADING DOSE Leflunomide therapy is started with a loading dose of 100mg once daily for 3 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 risk of haematologic or hepatic toxicity, such as those receiving concomitant treatment with methotrexate or other immunosuppressive agents or on such similar medications in the recent past. (_see Lugege kogu dokumenti