Šalis: Australija
kalba: anglų
Šaltinis: Department of Health (Therapeutic Goods Administration)
celecoxib, Quantity: 200 mg
Arrotex Pharmaceuticals Pty Ltd
Celecoxib
Capsule, hard
Excipient Ingredients: povidone; sodium lauryl sulfate; Gelatin; colloidal anhydrous silica; lactose monohydrate; magnesium stearate; croscarmellose sodium; titanium dioxide; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide
Oral
10, 60, 120, 30, 50, 20
(S4) Prescription Only Medicine
For the symptomatic treatment of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.,For the treatment of primary dysmenorrhoea in adults.,For the short-term treatment of acute pain in adults following surgery or musculoskeletal and/or soft tissue injury.
Visual Identification: Opaque, white to off-white capsules imprinted with 'CC' and '200' in black ink.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2014-05-29
CELECOXIB APOTEX CAPSULES 1 CELECOXIB APOTEX CAPSULES _Contains the active ingredient celecoxib _ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _ WHAT IS IN THIS LEAFLET READ THIS LEAFLET CAREFULLY BEFORE TAKING YOUR MEDICINE. This leaflet answers some common questions about celecoxib. 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 last page. More recent information on this medicine may be available. ASK YOUR DOCTOR OR PHARMACIST: • if there is anything you do not understand in this leaflet, • if you are worried about taking your medicine, or • to obtain the most up-to-date information. You can also download the most up to date leaflet from www.apotex.com.au. All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you. Pharmaceutical companies cannot give you medical advice or an individual diagnosis. Keep this leaflet with your medicine. You may want to read it again. WHAT THIS MEDICINE IS USED FOR The name of your medicine is Celecoxib APOTEX. It contains the active ingredient celecoxib. It is used to treat: • osteoarthritis, • rheumatoid arthritis • ankylosing spondylitis, a chronic inflammatory rheumatic disorder that primarily affects, but is not limited to, the spine. Celecoxib also provides short term pain relief in conditions such as: • menstrual cramps or period pain • after surgery • muscle and joint injuries. Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed this medicine for another reason. This medicine is available only with a doctor's prescription. _HOW IT WORKS _ Celecoxib belongs to a group of medicines called Coxibs which are used to relieve pain and inflammation in a number of conditions. Although Celecoxib APOTEX can relieve Perskaitykite visą dokumentą
1 AUSTRALIAN PRODUCT INFORMATION – CELECOXIB APOTEX (CELECOXIB) CAPSULES 1 NAME OF THE MEDICINE Celecoxib 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 100 mg or 200 mg celecoxib as the active ingredient. Excipients with known effect: lactose monohydrate. For the full list of excipients see Section 6.1 List of Excipients. 3 PHARMACEUTICAL FORM Capsule, hard. 100 mg capsules: opaque, white to off-white capsules imprinted with ‘CC’ and ‘100’ in black ink. 200 mg capsules: white to off-white capsules imprinted with ‘CC’ and ‘200’ in black ink. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ▪ For the symptomatic treatment of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis. ▪ For the treatment of primary dysmenorrhoea in adults. ▪ For the short-term treatment of acute pain in adults following surgery or musculoskeletal and/or soft tissue injury. 4.2 DOSE AND METHOD OF ADMINISTRATION DOSAGE As the cardiovascular risks of celecoxib may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used (see Section 5.1 Pharmacodynamic Properties, Clinical trials). Patients on long-term treatment should be reviewed regularly, with regard to efficacy, risk factors and ongoing need for treatment. Adults _Osteoarthritis _ 200 mg taken once daily or in two divided doses. _Rheumatoid arthritis _ 200 mg taken in two divided doses. 2 Up to 400 mg daily may be used for short-term management of disease flares or exacerbations. _Ankylosing spondylitis _ The maximum daily dose is 200 mg taken once daily or in two divided doses. _Primary dysmenorrhoea _ 400 mg as a single dose or divided on the first day, followed by 200 mg once daily on subsequent days. Patients may be instructed to take an additional dose of 200 mg on any given day, if needed. The maximum recommended treatment duration is 5 days. _Acute pain following surgery or musculoskeletal and/or soft tissue injury _ Loading dose of 400 mg then 200 mg once Perskaitykite visą dokumentą