ETHICAL

Main information

  • Trade name:
  • ETHICAL NUTRIENTS INNER HEALTH DAIRY FREE POWDER
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ETHICAL NUTRIENTS INNER HEALTH DAIRY FREE POWDER
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 215474
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

215474

ETHICAL NUTRIENTS INNER HEALTH DAIRY FREE POWDER

ARTG entry for

Medicine Listed

Sponsor

Health World Ltd

Postal Address

PO Box 675,VIRGINIA BC, QLD, 4014

Australia

ARTG Start Date

1/10/2013

Product category

Medicine

Status

Active

Approval area

Listed Medicines

Conditions

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

kept.

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.

Products

1. ETHICAL NUTRIENTS INNER HEALTH DAIRY FREE POWDER

Product Type

Single Medicine Product

Effective date

1/10/2013

Warnings

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

Prolonged use may cause serious bowel problems.

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).

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

Standard Indications

Relief or treatment of diarrhoea. [Warning DIAR required]

May help prevent dental caries

Aids or assists in the relief of constipation. [Warnings S and LAX1 required / LAX2 required in certain circumstances]

May assist in the management of allergies. [Warning S required]

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

For the symptomatic relief of allergies. [Warning S required]

Specific Indications

May assist in maintaining the levels of normal flora (friendly bacteria) that may have been disrupted after prolonged use of antibiotics.

Helps maintain the intestinal microbiological balance of the body, promoting and assisting in general well-being.

Promote the growth of friendly bacteria and help maintain healthy digestive function.

High potency probiotic powder plus oligosaccharides.

Lactobacillus acidophilus (NCFM) may assist with the maintenance of normal vagina flora which is known to be disrupted after prolonged use of the ****

pill.

Ultra Flora Plus DF has been specifically formulated for those who are dairy intolerant.

Oligosaccharides are included to boost the growth of bifidobacteria and production of short chain fatty acids (Butyrate).

To promote the growth and adherance of beneficial intestinal bacteriaid dairy or lactose intolerant people.

If you have been taking a course of antibiotics a probiotic such as Inner Health Dairy Free Powder may assist in maintaining the balance of good

bacteria.

Aids in the maintenance of a normal healthy gastrointestinal system and digestive function.

Helps improve general wellbeing.

Public Summary

Page 1 of

Produced at 26.11.2017 at 08:40:47 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

Assists in redicing the risk of progressive tooth decay.

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Powder, oral

Route of Administration

Oral

Visual Identification

Active Ingredients

Bifidobacterium lactis

5 billion organisms/g

Lactobacillus acidophilus

5 billion organisms/g

Oligofructose

120 mg/g

© 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 2 of

Produced at 26.11.2017 at 08:40:47 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