国家: 澳大利亚
语言: 英文
来源: Department of Health (Therapeutic Goods Administration)
lactulose solution, Quantity: 1 mL/mL (Equivalent: lactulose, Qty 660 mg/mL)
Alphapharm Pty Ltd
Oral Liquid, solution
Excipient Ingredients:
Oral
500mL
Not scheduled. Not considered by committee
For the treatment of acute, and the prevention and treatment of chronic portal-systemic encephalopathy, including the stages of hepatic precoma and coma. For the treatment of chronic and habitual constipation.
Visual Identification: A clear, viscous liquid, colourless or pale brownish-yellow, which is miscible with water.; Container Type: Bottle; Container Material: Polyethylene Terephthalate; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Registered
1993-03-24
AUSTRALIAN PRODUCT INFORMATION ACTILAX _Lactulose _ 1 NAME OF THE MEDICINE Lactulose 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Lactulose solution is an aqueous solution of lactulose (4- _O_ - -D-galacto-pyranosyl-D-fructose) and other sugars including lactose, galactose, tagatose and epilactose. Each 5 mL contains lactulose 3.3 g, and lesser amounts of other sugars including lactose, galactose, tagatose and epilactose. Excipients with known effect: sugars (as lactose, galactose and others).and traces of sulfites. 3 PHARMACEUTICAL FORM Actilax oral liquid is a clear, viscous liquid, colourless or pale brownish-yellow, which is miscible with water. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 1. Treatment of acute, and prevention and treatment of chronic Portal-Systemic Encephalopathy (PSE), including the stages of hepatic precoma and coma. 2. Treatment of chronic and habitual constipation. Controlled clinical studies in patients with a history of chronic constipation have shown that lactulose therapy causes a significant increase in the number of bowel movements per day and the number of days on which bowel movements occur. 4.2 DOSE AND METHOD OF ADMINISTRATION The lactulose solution may be administered diluted or undiluted. The dose should be titrated according to the clinical response. A single dose of lactulose should be swallowed in one and should not be kept in the mouth for an extended period of time. _PORTAL-SYSTEMIC ENCEPHALOPATHY_. The safety and efficacy of lactulose use in children (newborn to 18 years of age) with PSE have not been established. No data are available. Dosing in PSE (for adults only): The usual dosage is 30 to 45mL three or four times daily. The dosage may be adjusted every day or two to produce two or three soft stools daily. Hourly doses of 30 to 45 mL of Actilax solution may be used to induce the rapid laxation indicated in the initial phase of the therapy of PSE. When the laxative effect has been achieved, the dose of Actilax may then be reduced to the recommended daily do 阅读完整的文件