Land: Australien
Sprache: Englisch
Quelle: Department of Health (Therapeutic Goods Administration)
prednisolone, Quantity: 25 mg
Aspen Pharmacare Australia Pty Ltd
Tablet, uncoated
Excipient Ingredients: maize starch; crospovidone; magnesium stearate; lactose monohydrate; povidone
Oral
30, 1000, 500, 100, bulk
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; 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
Visual Identification: Round, biconvex, white, scored tablet debossed with "PL/25" on one side and plain on the other.; Container Type: Bottle; Container Material: HDPE; 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
PANAFCORTELONE 1 PANAFCORTELONE _prednisolone _ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Panafcortelone. It does not contain all the information that is known about Panafcortelone. 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 Panafcortelone 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 PANAFCORTELONE IS USED FOR Panafcortelone contains prednisolone as the active ingredient. Prednisolone belongs to a group of medicines called corticosteroids which are a synthetic version of a naturally occurring body hormone called cortisol. Panafcortelone works by entering inflammatory cells and blocking the inflammatory reaction. This medicine is only able to prevent or reduce symptoms of your condition, it does not cure it. Panafcortelone is used in the treatment of many different conditions. Some of these conditions include: severe allergies, severe or chronic asthma, skin problems, arthritis, inflammatory diseases of the bowel, 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. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY PANAFCORTELONE 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 PANAFCORTELONE IF YOU HAVE EVER HAD AN ALLERGIC REACTION TO: prednisolone or prednisone any of the ingredients listed at the end of this leaflet. Symptoms of an allergic reac Lesen Sie das vollständige Dokument
1 AUSTRALIAN PRODUCT INFORMATION PANAFCORTELONE (PREDNISOLONE) TABLETS 1 NAME OF THE MEDICINE Prednisolone. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION PANAFCORTELONE tablets contain either 1 mg, 5 mg or 25 mg of the active prednisolone. List of excipients with known effects: lactose monohydrate. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM 1 mg: Round, flat, white scored tablet debossed with ‘PL/1’ on one side and plain on the other. 5 mg: Round, flat, white scored tablet debossed with ‘PL/5’ on one side and plain on the other. 25 mg: Round, biconvex, white scored tablet debossed with ‘PL/25’ on one side and plain on the other. 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 The severity, prognosis, expected duration of the disease, and the patient's reaction to medication are primary factors in determining dosage. Despite the 1 mg tablet being scored, it should not be broken. Adults: The initial adult dosage may range from 20 to 40 mg daily, but can be 60 to 80 mg daily if necessary, depending on the disease being treated. Maintenance dosage: Usually 5 to 20 mg daily. In long term therapy the ideal dosage should not be greater than 40 mg per 2 day so as to minimise side-effects. It is usually administered in 2-4 divided doses or as a single daily dose after breakfast or on alternate day Lesen Sie das vollständige Dokument