SURLAX

Main information

  • Trade name:
  • SURLAX ORAL LIQUID lactulose 667 mg/mL bottle
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • SURLAX ORAL LIQUID lactulose 667 mg/mL bottle
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220097
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220097

SURLAX ORAL LIQUID lactulose 667 mg/mL bottle

ARTG entry for

Medicine Registered

Sponsor

Aspen Pharma Pty Ltd

Postal Address

34-36 Chandos Street,ST LEONARDS, NSW, 2065

Australia

ARTG Start Date

13/02/2014

Product category

Medicine

Status

Active

Approval area

Non-Prescription Medicines

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. SURLAX ORAL LIQUID lactulose 667 mg/mL bottle

Product Type

Single Medicine Product

Effective date

13/02/2014

Warnings

No Warnings included on Record

Standard Indications

Specific Indications

Treatment of acute, and prevention and treatment of chronic portal-systemic encephalopathy (PSE), including the stages of hepatic pre-coma and

coma.,Treatment of chronic and habitual constipation.,Where a soft stool is considered of medical benefit (haemorrhoids, post-colonic/anal surgery).

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

Not recorded

2 Years

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

200 mL

Not scheduled. Not considered by committee

Components

1.

Dosage Form

Oral Liquid

Route of Administration

Oral

Visual Identification

Clear, colourless to brownish-yellow, viscous liquid.

Active Ingredients

Lactulose

667 mg/mL

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 26.11.2017 at 02:50:20 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information