Main information

  • Trade name:
  • Pro4-50 D-Lactate Free
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug



  • Available in:
  • Pro4-50 D-Lactate Free
  • Language:
  • English

Other information


  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222399
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:


Pro4-50 D-Lactate Free

ARTG entry for

Medicine Listed


Spectrumceuticals Pty Ltd

Postal Address

10/5 Narabang Way,BELROSE, NSW, 2085


ARTG Start Date


Product category




Approval area

Listed Medicines


Colouring agents used in listed medicine for ingestion, other than those listed for export only under section 25 of the Act, shall be only those included in

the list of 'Colourings permitted in medicines for oral use'.

The sponsor shall keep records relating to this listed medicine as are necessary to: (a) Expedite recall if necessary of any batch of the listed medicine,

(b) Identify the manufacturer(s) of each batch of the listed medicine. Where any part of or step in manufacture in Australia of the listed medicine is

sub-contracted to a third party who is not the sponsor, copies of relevant Good Manufacturing Practice agreements relation to such manufacture shall be


The sponsor shall retain records of the distribution of the listed medicine for a period of five years and shall provide the records or copies of the records

to the Complementary Medicines Branch, Therapeutic Goods Administration, upon request.

The sponsor of the listed medicine must not, by any means, intentionally or recklessly advertise the medicine for an indication other than those accepted

in relation to the inclusion of the medicine in the Register.

All reports of adverse reactions or similar experiences associated with the use or administration of the listed medicine shall be notified to the Head, Office

of Product Review, Therapeutic Goods Administration, as soon as practicable after the sponsor of the goods becomes aware of those reports. Sponsors

of listed medicines must retain records of such reports for a period of not less than 18 months from the day the Head, Office of Product Review is notified

of the report or reports.

The sponsor shall not supply the listed medicine after the expiry date of the goods.

Where a listed medicine is distributed overseas as well as in Australia, product recall or any other regulatory action taken in relation to the medicine

outside Australia which has or may have relevance to the quality, safety or efficacy of the goods distributed in Australia, must be notified to the National

Manager Therapeutic Goods Administration, immediately the action or information is known to the sponsor.


1. Pro4-50 D-Lactate Free

Product Type

Single Medicine Product

Effective date



If symptoms persist consult your healthcare practitioner (or words to that effect).

If diarrhoea persists for more than 6 hours in infants under 6 months, 12 hours in children under 3 years, 24 hours in children aged 3-6 years or 48 hours

in adults and children over 6 years, seek medical advice (or words to that effect).

Drink plenty of water (or words to that effect).

Standard Indications

May assist in the management of medically diagnosed irritable bowel syndrome

For the symptomatic relief of medically diagnosed irritable bowel syndrome

Aids, assists or helps in the maintenance or improvement of general well-being.

For the symptomatic relief of constipation. [Warnings S and LAX1 required / LAX2 required in certain circumstances]

Specific Indications

Supplementation during pregnancy and whilst breastfeeding may support healthy immune function of the newborn after birth

Lactobacillus rhamnosus supplementation by expectant mothers prior to birth and may assist in healthy gastrointestinal colonisation of the newborn for

the first few months of life

Lactobacillus rhamnosus and Bifidobacteria lactis taken during pregnancy and post natally whilst breastfeeding decreases the incidence of atopic

dermatitis/allergy in children in their first years of life

Supports healthy gastrointestinal microflora after a course of antiobiotic

Lactobacillus rhamnosus is a commensal microorganism that inhabits the human intestinal mucosa, contributing to digestive function

Lactobacillus rhamnosus may provide temporary relief of diarrhoea

Lactobacillus rhamnosus colonise the urogenital and intestinal tracts and assist in restoring and maintaining urogenital flora/health

Bifidobacteria species found in the rectum/intestinal tract may contribute to the maintenance of normal healthy vaginal flora

Bifidobacterium lactis is a commensal microorganism that inhabits the human intestinal mucosa and contributes to healthy digestive function

Additional Product information

Public Summary

Page 1 of

Produced at 23.11.2017 at 12:18:20 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 for contact information

Container information



Life Time





Not recorded

Not recorded

Not recorded

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule


1. Formulation 1

Dosage Form

Capsule, hard

Route of Administration


Visual Identification

Active Ingredients

Bifidobacterium breve

5 billion CFU

Bifidobacterium lactis

15 billion CFU

Bifidobacterium longum

5 billion CFU

Lactobacillus rhamnosus

25 billion CFU

© 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

Public Summary

Page 2 of

Produced at 23.11.2017 at 12:18:20 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 for contact information