ACTILAX lactulose 660 mg/mL oral liquid bottle

Land: Australië

Taal: Engels

Bron: Department of Health (Therapeutic Goods Administration)

Werkstoffen:

lactulose solution, Quantity: 1 mL/mL (Equivalent: lactulose, Qty 660 mg/mL)

Beschikbaar vanaf:

Alphapharm Pty Ltd

farmaceutische vorm:

Oral Liquid, solution

Samenstelling:

Excipient Ingredients:

Toedieningsweg:

Oral

Eenheden in pakket:

500mL

Prescription-type:

Not scheduled. Not considered by committee

therapeutische indicaties:

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.

Product samenvatting:

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

Autorisatie-status:

Registered

Autorisatie datum:

1993-03-24

Productkenmerken

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