Isotonix

Main information

Documents

Localization

  • Available in:
  • Isotonix Advanced B-Complex
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220783
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220783

Isotonix Advanced B-Complex

ARTG entry for

Medicine Listed

Sponsor

Market Australia Inc

Postal Address

Unit 1/1 Tucks Road,SEVEN HILLS, NSW, 2147

Australia

ARTG Start Date

6/03/2014

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. Isotonix Advanced B-Complex

Product Type

Single Medicine Product

Effective date

17/07/2014

Warnings

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

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

(If medicine contains one sugar) contains [insert name of sugar] OR (If medicine contains two or more sugars) Contains sugars [or words to that effect].

Standard Indications

Specific Indications

Deficiencies in folic acid, vitamin B12, vitamin B6 or Biotin may result in feelings of fatigue.

Helps maintain healthy levels of serotonin.

May help support markers of DNA stability.

May help in the maintenance of long term health.

May help support DNA integrity which is a marker of ageing.

Meets need for the B vitamins in a vegetarian diet.

Promotes normal cognitive performance.

Vitamin B12 and Folic acid facilitate steps required for cell division.

Vitamin B5 is involved in the Krebs cycle of energy production and is needed to make the neurotransmitter acetylcholine. B5 is also essential in

producing, transporting and releasing energy from fats.

Vitamin B6 is essential for amino acid metabolism.

Vitamins B1, B2, B3, and Biotin participate in different aspects of energy production.

Folic acid helps form building blocks of RNA, needed for protein synthesis in all cells.

Promotes normal red blood cell formation.

Involved in the metabolism of proteins, fats and carbohydrates.

Promotes a healthy nervous system, bone marrow and intestinal tract (B vitamins deficiencies appear first in these tissues).

Increases energy.

May help decrease stress and improve mood.

Promotes healthy ageing.

Promotes cardiovascular health.

Promotes healthy levels of homocysteine and supports normal endothelial function.

Additional Product information

Container information

Public Summary

Page 1 of

Produced at 22.11.2017 at 11:29:16 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

Type

Material

Life Time

Temperature

Closure

Conditions

Multiple containers

Not recorded

Not recorded

Not recorded

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Powder, oral

Route of Administration

Oral

Visual Identification

Active Ingredients

Biotin

90.9091 microgram/g

Calcium pantothenate

7.4074 mg/g

Cyanocobalamin

36.3636 microgram/g

Folic acid

151.5151 microgram/g

magnesium carbonate hydrate

50.505 mg/g

Nicotinamide

6.122 mg/g

pyridoxine hydrochloride

1.8476 mg/g

Riboflavin

681.8182 microgram/g

Thiamine hydrochloride

688.788 microgram/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 22.11.2017 at 11:29:16 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