Ország: Ausztrália
Nyelv: angol
Forrás: Department of Health (Therapeutic Goods Administration)
dexamethasone, Quantity: 0.5 mg
Aspen Pharmacare Australia Pty Ltd
Tablet, uncoated
Excipient Ingredients: povidone; lactose monohydrate; magnesium stearate; wheat starch
Oral
100, 1000, bulk tablets, 30
Medicine Registered
(S4) Prescription Only Medicine
Wherever corticosteroid therapy is indicated such as: pemphigus vulgaris, allergic dermatitis, eczema, exfoliative dermatitis, dermatitis herpetiformis, dermatitis medicamentosa, erythema multiforme; disseminated lupus erythematosus, dermatomyositis, polyarteritis nodosa; severe bronchial asthma and status asthmaticus, emphysema, pulmonary fibrosis; andrenal hyperplasia (adrenogenital syndrome); idiopathic thrombocytopenic purpura, acquired haemolytic anaemia, acute leukaemia; nephroticsyndrome; iridochoroiditis; ulcerative colitis; rheumatoid arthritis; ankylosing spondylitis, rheumatic fever, gout, periarthritis of the shoulder.
Visual Identification: round, slightly biconvex, white tablets plain on one side and 'DS/0.5' with breakline on the other; Container Type: Bottle; Container Material: Glass Type I Coloured; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
1991-10-21
DEXMETHSONE- CMI Page 1 of 5 DEXMETHSONE _ _ _dexamethasone _ _ _ _ _ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about DEXMETHSONE. 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 taking DEXMETHSONE 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 DEXMETHSONE IS USED FOR DEXMETHSONE contains dexamethasone as the active ingredient. It belongs to a group of medicines called corticosteroids which are a synthetic version of a naturally occurring body hormone called cortisol. DEXMETHSONE is used in the treatment of many different conditions including severe allergies, severe or chronic asthma, skin problems, arthritis, inflammatory diseases of the bowel, some types of cancer and “auto- immune” diseases. It is also used to prevent or reduce the symptoms of inflammation (such as swelling, redness, pain, tenderness or itching) in any part of the body. These symptoms can occur in response to injury or can be caused by many different conditions. DEXMETHSONE works by acting on the immune system and blocking the production of substances that trigger allergic and inflammatory actions. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY DEXMETHSONE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another purpose. This medicine is only available with a doctor’s prescription. There is no evidence that it is addictive. BEFORE YOU TAKE IT _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE DEXMETHSONE IF YOU HAVE EVER HAD AN ALLERGIC REACTION TO: • dexamethasone • any of the ingredients listed at the end of this leaflet. Symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty in breathing; swelling of the face, l Olvassa el a teljes dokumentumot
Dexmethsone (dexamethasone) tablets – PI Page 1 AUSTRALIAN PRODUCT INFORMATION DEXMETHSONE (DEXAMETHASONE) TABLETS 1 NAME OF THE MEDICINE Dexamethasone. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Dexamethasone is a white or almost white, crystalline powder. It is practically insoluble in water, sparingly soluble in anhydrous ethanol, slightly soluble in methylene chloride. Each DEXMETHSONE tablet contains either 0.5 mg or 4 mg of dexamethasone as the active ingredient. Excipients include lactose monohydrate and wheat starch (0.5 mg tablet). For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM 0.5 mg: Round, slightly biconvex, white tablets plain on one side and 'DS/0.5' with breakline on the other side. 4 mg: Round, white tablets plain on one side and 'DS/4' with breakline on the other side. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Wherever corticosteroid therapy is indicated such as: pemphigus vulgaris, allergic dermatitis, eczema, exfoliative dermatitis, dermatitis herpetiformis, dermatitis medicamentosa, erythema multiforme; disseminated lupus erythematosus, dermatomyositis, polyarteritis nodosa; severe bronchial asthma and status asthmaticus, emphysema, pulmonary fibrosis; adrenal hyperplasia (adrenogenital syndrome); idiopathic thrombocytopenic purpura, acquired haemolytic anaemia, acute leukaemia; nephrotic syndrome; iridochoroiditis; ulcerative colitis; rheumatoid arthritis; ankylosing spondylitis, rheumatic fever, gout, periarthritis of the shoulder. 4.2 D OSE AND METHOD OF ADMINISTRATION Adults: 0.5 to 10 mg daily in divided doses, gradually reduced after good effect is achieved to a maintenance dosage of 0.5 to 1 mg daily. In potentially fatal conditions, much larger doses may be given for acute rheumatic carditis, acute leukaemia, the nephrotic syndrome and pemphigus. Instructions to patients: Patients should be warned of the long term adverse effects of corticosteroids. The necessity for increasing dosage in situations of intercurrent stress or infect Olvassa el a teljes dokumentumot