Krajina: Austrália
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
prednisolone sodium phosphate, Quantity: 6.72 mg/mL (Equivalent: prednisolone, Qty 5 mg/mL)
Aspen Pharmacare Australia Pty Ltd
Oral Liquid, solution
Excipient Ingredients: propylene glycol; dibasic sodium phosphate dodecahydrate; monobasic sodium phosphate; disodium edetate; methyl hydroxybenzoate; propyl hydroxybenzoate; purified water
Oral
30mL
(S4) Prescription Only Medicine
Whenever corticosteroid therapy is indicated.
Visual Identification: Clear, colourless, liquid free from haze and substantially free from particulate matter; Container Type: Bottle; Container Life Time: 18 Months; Container Temperature: Store at 2 to 8 degrees Celsius
Registered
1999-01-19
PREDMIX ORAL LIQUID – Consumer Medicine Information Page 1 of 5 PREDMIX ORAL LIQUID _prednisolone sodium phosphate _ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about PredMix Oral Liquid. It does not contain all the information that is known about PredMix Oral Liquid. 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 PredMix Oral Liquid 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 PREDMIX ORAL LIQUID IS USED FOR PredMix Oral Liquid contains prednisolone sodium phosphate which is changed to prednisolone after it enters the body. Prednisolone belongs to a group of medicines called corticosteroids. It is a synthetic version of a naturally occurring body hormone called cortisol. It 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. PredMix Oral Liquid 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. PredMix Oral Liquid 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 PREDMIX ORAL LIQUID HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. 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 PREDMIX ORAL LIQUID IF YO Prečítajte si celý dokument
Predmix – Product Information Page 1 of 10 AUSTRALIAN PRODUCT INFORMATION PREDMIX (PREDNISOLONE SODIUM PHOSPHATE) ORAL LIQUID 1 NAME OF THE MEDICINE Prednisolone sodium phosphate. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Predmix contains the active ingredient prednisolone sodium phosphate 7.06 mg/1 mL equivalent to prednisolone 5 mg/1 mL. It contains excipients with known effect, methyl hydroxybenzoate and propyl hydroxybenzoate. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Predmix is a clear, colourless liquid free from haze and substantially free from particulate matter. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Whenever corticosteroid therapy is indicated. 4.2 D OSE AND METHOD OF ADMINISTRATION Dosage should be individualised according to severity of condition and response of patient. _ _ CHILDREN: Asthma: 1 mg/kg once daily Croup: 1 mg/kg/dose every 8-12 hours for 48 hours Physiological replacement: 4-5 mg/m 2 /day (Preferable to use shorter acting steroid to avoid growth suppression) Infantile spasms, intractable epilepsy: 2 mg/kg/day Nephrotic syndrome: 2 mg/kg/day (max 80 mg/day) until protein free urine for 5 days. Increase to 4 mg/kg/day (max 120 mg/day) if no response within 28 days. Autoimmune liver disease, Crohn's disease, Ulcerative colitis: 2 mg/kg/day for initial control, reducing over 2 months to a maintenance dose of 5 mg/day or less (or cease). _ _ ADULTS: 10-40 mg daily (up to 100 mg can be used in divided doses) reducing gradually when control is achieved to the lowest possible dose (5-20 mg). Predmix – Product Information Page 2 of 10 4.3 C ONTRAINDICATIONS Patients with active or doubtfully quiescent tuberculosis should not be given Predmix Oral Liquid except as an adjunct to treatment with tuberculostatic drugs. Systemic fungal infections and known hypersensitivity to prednisolone or any of the excipients_. _ 4.4 S PECIAL WARNINGS AND PRECAUTIONS FOR USE SCLERODERMA RENAL CRISIS: Caution is required in patients with systemic scl Prečítajte si celý dokument