ประเทศ: ออสเตรเลีย
ภาษา: อังกฤษ
แหล่งที่มา: Department of Health (Therapeutic Goods Administration)
prednisolone sodium phosphate, Quantity: 6.72 mg (Equivalent: prednisolone, Qty 5 mg)
Aspen Pharma Pty Ltd
Suppository, moulded
Excipient Ingredients: Hard fat
Rectal
10 suppositories
(S4) Prescription Only Medicine
INDICATIONS AS AT 01 JAN 1991 : PREDSOL SUPPOSITORIES are indicated for the treatment of haemorrhagic and granular proctitis, post-radiation proctitis and rectal complication of Crohn's disease.
Visual Identification: White to off-white suppositories of regular shape with no defects, air occulsion or dirt present.; Container Type: Strip Pack; Container Material: PVC/PVDC/PE; Container Life Time: 30 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
1996-09-17
PREDSOL suppository and enema – Consumer Medicine Information Page 1 of 4 PREDSOL SUPPOSITORY AND RETENTION ENEMA _prednisolone (as sodium phosphate) _ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS THIS LEAFLET This leaflet answers some common questions about PREDSOL Suppositories and PREDSOL retention enemas. 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 using PREDSOL 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 PREDSOL IS USED FOR The active ingredient in PREDSOL is prednisolone (as sodium phosphate), which is a type of glucocorticoid belonging to a group of medicines called corticosteroids. PREDSOL suppositories are used in the treatment of many different conditions such as: • haemorrhagic and granular proctitis (a type of inflammation in the rectum) • post radiation proctitis (inflammation in the rectum following radiation therapy) • rectal complications of Crohn’s disease (inflammation of the intestine). PREDSOL retention enemas are used in the treatment of ulcerative colitis and Crohn’s disease. PREDSOL suppositories and PREDSOL retention enemas are for use in the rectum only. They should not be taken by mouth. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY PREDSOL HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason, for example, haemorrhoids. This medicine is only available with a doctor’s prescription. BEFORE YOU USE IT _WHEN YOU MUST NOT USE IT _ _ _ DO NOT USE PREDSOL IF YOU ARE ALLERGIC TO PREDNISOLONE OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. DO NOT USE PREDSOL IF YOU HAVE: • tuberculous and fungal infections (such as tinea, thrush or ringworm) of the skin • acute herpes simplex (such as cold sores, shingles or chic อ่านเอกสารฉบับเต็ม
1 AUSTRALIAN PRODUCT INFORMATION PREDSOL AND PREDSOL RETENTION ENEMA (PREDNISOLONE (AS SODIUM PHOSPHATE)) SUPPOSITORY AND ENEMA 1 NAME OF THE MEDICINE Prednisolone (as sodium phosphate). 2 QUALITATIVE AND QUANTITATIVE COMPOSITION PREDSOL SUPPOSITORY contains prednisolone 5 mg (as sodium phosphate). PREDSOL RETENTION ENEMA contains prednisolone 20 mg/100 mL (as sodium phosphate). List of excipients with known effect: Nipastat GL75 which contains methyl hydroxybenzoate, ethyl hydroxybenzoate, propyl hydroxybenzoate, butyl hydroxybenzoate and isobutyl hydroxybenzoate. For the full list of excipients, see section 6.1 List of excipients. 3 PHARMACEUTICAL FORM PREDSOL SUPPOSITORY is a white to off white suppository of regular shape with no defects, air occlusion or dirt present. PREDSOL RETENTION ENEMA is a clear, colourless liquid free from haze and substantially free from particulate matter. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS PREDSOL SUPPOSITORY is indicated for the treatment of haemorrhagic and granular proctitis, post-radiation proctitis and rectal complication of Crohn’s disease. PREDSOL RETENTION ENEMA provides local corticosteroid treatment for rectal and rectosigmoidal disease in ulcerative colitis and Crohn’s disease. 4.2 D OSE AND METHOD OF ADMINISTRATION PREDSOL SUPPOSITORY: Administer twice daily, one at bedtime and the other after morning defecation. When response is good treatment should be continued for some months, or ideally, until sigmoidoscopic or protoscopic appearances are normal. If symptoms recur, treatment should at once be resumed. 2 PREDSOL RETENTION ENEMA: Use one enema nightly on retiring, for two to four weeks. Treatment may be continued in patients showing progressive improvement but it should not be persisted with if the response has been inadequate. Some patients may relapse after an interval but are likely to respond equally well to a repeated course of treatment. THE ENEMA, AS PACKED, IS NOT SUITABLE FOR USE IN CHILDREN. It may be warmed before administration by pl อ่านเอกสารฉบับเต็ม