ETHICAL

Main information

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

Documents

Localization

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

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 215745
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

215745

ETHICAL NUTRIENTS INNER HEALTH POWDER

ARTG entry for

Medicine Listed

Sponsor

Health World Ltd

Postal Address

PO Box 675,VIRGINIA BC, QLD, 4014

Australia

ARTG Start Date

8/10/2013

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 POWDER

Product Type

Single Medicine Product

Effective date

8/10/2013

Warnings

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

Products containing bovine colostrum powder contain lactose and cow's milk proteins (or words to that effect). This product is not suitable for use in

children under the age of 12 months except on professional health advice.

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).

Prolonged use may cause serious bowel problems.

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

Standard Indications

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

May help prevent dental caries

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

Relief or treatment of diarrhoea. [Warning DIAR required]

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

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

Specific Indications

Contains probioplex which is useful in maintaining normal intestinal flora.

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.Contains therapeutic strains of

Lactobacilus acidophilus (NCFM) and Bifidobacterium lactis in a specially formulated matrix (Probioplex and Colostrum ) to provide a broad spectrum

approach to probiotic supplementation.

Maintain a healthy normal immune system.

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

To assist in the maintenance of a healthy normal gastrointestinal andimmune system.Lactobacillus acidophilus (NCFM) may assist with the maintenance

of normal vagina flora which is known to be disrupted after prolonged use of the contraceptivee pill.

Contains colostrum which is useful in maintaining normal healthy immune function.

Contains probioplex which is useful in maintaining normal intestinal flora.

Public Summary

Page 1 of

Produced at 26.11.2017 at 08:11:53 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

Nutrient ingredients will assist with normal healthy development.

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

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

Helps improve general wellbeing.

Assists in reducing 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

bovine colostrum powder

100 mg/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 08:11:53 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