METAGENICS

Main information

Documents

Localization

  • Available in:
  • METAGENICS GLUTAGENICS
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 213315
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

213315

METAGENICS GLUTAGENICS

ARTG entry for

Medicine Listed

Sponsor

Health World Ltd

Postal Address

PO Box 675,VIRGINIA BC, QLD, 4014

Australia

ARTG Start Date

19/08/2013

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. METAGENICS GLUTAGENICS

Product Type

Single Medicine Product

Effective date

13/02/2014

Warnings

Vitamins can only be of assistance if the dietary vitamin intake is inadequate. OR Vitamin supplements should not replace a balanced diet.

WARNING - When taken in excess of 3000 micrograms retinol equivalents, vitamin A can cause birth defects.

If you are pregnant, or considering becoming pregnant, do not take vitamin A supplements without consulting your doctor or pharmacist.

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

WARNING: May be dangerous if taken in large amounts or for a long period. OR WARNING: Contains zinc which may be dangerous if taken in large

amounts or for a long period (or words to that effect).

The recommended daily amount of vitamin A from all sources is 700 micrograms retinol equivalents for women and 900 micrograms retinol equivalents

for men.

Standard Indications

Aids digestion.

Specific Indications

Glutamine, aloe vera and zinc may have a protective effect on the gastrointestinal mucosa and support gastrointestinal health.

Glutamine protects/preserves gut integrity and permeability.

Glutamine may be a source of nutrition and fuel for the cells in the intestine.

Vitamin A supports epithelial barrier function and mucosal immunity to assist in the maintenance of gastrointestinal health.

Glutamine and zinc protect the intestinal/gut lining wall.

Boswellia has been used to support gastrointestinal health in traditional Ayurvedic medicine.

Larch arabinogalactan is a nondigestible soluble dietary fibre which has a prebiotic activity and can increase short-chain fatty acid production (butyrate)

and stimulate the growth of bifidobacteria and lactobacilli.

Aloe vera has been used for minor gastrointestinal inflammation/to help relieve minor inflammation of the gastrointestinal tract, in traditional Western

herbal medicine.

Boswellia has been used for minor gastrointestinal inflammation/to help relieve minor inflammation of the gastrointestinal tract, in traditional Ayurvedic

medicine.

Public Summary

Page 1 of

Produced at 26.11.2017 at 11:16:26 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

Aloe vera has been used as a demulcent/soothing preparation for the symptomatic relief of mild GI discomfort in traditional Western herbal medicine.

Boswellia has been used as an antispasmodic and to relieve pain in traditional Ayurvedic medicine.

Glutamine and zinc may assist with repair of the gastrointestinal/gut wall lining.

Vitamin D may support general well-being and gastrointestinal immunity.

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Oral Liquid, powder for

Route of Administration

Oral

Visual Identification

Active Ingredients

Aloe vera

3.25 mg/g

Equivalent: Aloe vera (Fresh)

649.35 mg/g

Boswellia serrata

19.48 mg/g

Equivalent: Boswellia serrata (Fresh)

194.8 mg/g

colecalciferol

1.6233 microgram/g

Glutamine

285.71 mg/g

Larix arabinogalactan

259.74 mg/g

retinol palmitate

178.5712 microgram/g

zinc amino acid chelate

9.74 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 11:16:26 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