Glutamine

Main information

  • Trade name:
  • Glutamine Powder
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Glutamine Powder
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220523
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220523

Glutamine Powder

ARTG entry for

Medicine Listed

Sponsor

FIT-BioCeuticals Limited

Postal Address

PO Box 6454,ALEXANDRIA, NSW, 2015

Australia

ARTG Start Date

26/02/2014

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. Glutamine Powder

Product Type

Single Medicine Product

Effective date

9/02/2016

Warnings

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

Standard Indications

Beneficial during times of stress. [Warning S required]

Helps maintain healthy digestive function.

Specific Indications

P390 Helps maintain healthy digestive function

P678 Beneficial in times of stress

P111Helps to maintain immune function

P114 Supports a healthy immune function

P140 Helps restore plasma glutamine levels depleted after periods of physical stress including prolonged exercise

P38 Helps to assist in muscle cell repair after exercise

P691 Supports energy production

1a.Glutamine is important for maintaining intestinal function, immune response and amino acid homeostasis during times of stress.

1b. Glutamine is important for gastrointestinal mucosal / epithelial cell differentiation, growth, functioning and repair.

1c. Glutamine helps support digestive system health after periods of physical stress

2a. Glutamine helps to maintain gut-associated lymphoid tissue and secretory IgA, which inhibits the attachment of undesired bacteria to mucosal cells.

2b. Glutamine supports immune health after periods of physical stress

2c. Glutamine is an important energy source for immune cells (lymphocytes and macrophages) and thereby supports healthy immune function.

3a. Glutamine assists recovery following strenuous exercise (by replenishing depleted glutamine stores, supporting muscle glycogen resynthesis /

gluconeogensis) and may help avoid the development of overtraining syndrome.

3b. Glutamine supports healthy physical performance in athletes

3c. Glutamine assists the growth and maintenance of healthy muscles.

4. Glutamine may support glutathione antioxidant pathways.

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Public Summary

Page 1 of

Produced at 26.11.2017 at 02:22:33 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

Components

1. Formulation 1

Dosage Form

Powder

Route of Administration

Oral

Visual Identification

Active Ingredients

Glutamine

1 g/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 02:22:33 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