METAGENICS

Main information

Documents

Localization

  • Available in:
  • METAGENICS CARDIOX TROPICAL FLAVOUR
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220350
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220350

METAGENICS CARDIOX TROPICAL FLAVOUR

ARTG entry for

Medicine Listed

Sponsor

Health World Ltd

Postal Address

PO Box 675,VIRGINIA BC, QLD, 4014

Australia

ARTG Start Date

21/02/2014

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. METAGENICS CARDIOX TROPICAL FLAVOUR

Product Type

Single Medicine Product

Effective date

21/02/2014

Warnings

This product contains selenium which is toxic in high doses. A daily dose of 150 micrograms for adults of selenium from dietary supplements should not

be exceeded.

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.

Standard Indications

May assist in the maintenance of normal healthy blood sugar/glucose levels in healthy individuals.

For mineral (may state the mineral) supplementation.

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

For vitamin (may state the vitamin) supplementation.

May assist in the maintenance of normal blood pressure in healthy individuals.

Specific Indications

CardioX may assist in the management of dietary folate deficiency.

Magnesium may assist in the management of physical and psychological stress in athletes.

Amino acid chelates have been shown to be highly bioavailable sources of minerals. 100% fully reacted magnesium diglycinate. MetaMag is an

exclusive and highly bioavailable form of magnesium. Magnesium amino acid chelates have a greater absorption than other magnesium salts, such as

chlorides, sulfites and oxides. Normal blood pressure is defined as systolic < 120 mmHg and diastolic < 80 mmHg. Pyridoxal 5 phosphate is the

metabolically active form of vitamin B6 and may be a superior form for supplementation as it bypasses the usual requirement for conversion.

Riboflavin-5-phosphate is the metabolically active coenzyme form of riboflavin. Calcium folinate is an alternative supplemental form of folic acid that

bypasses some of the steps in the conversion of folic acid to the active form, 5-methyltetrahydrofolate.

To assist cardiovascular health. With biologically active B vitamins. CardioX is a great tasting formula to support cardiovascular health. CardioX contains

Meta Mag, an exclusive and highly bioavailable form of magnesium, and taurine which may support normal blood pressure in healthy people. CardioX

may be particularly beneficial in times of stress and for a healthy cardiovascular system. It contains the biologically active form of vitamin B6, pyridoxal

5-phosphate, plus folinic acid, riboflavin and vitamin B12 which may help support healthy homocysteine levels. Chromium may assist in maintaining

normal blood sugar levels in healthy people.

Magnesium may be beneficial during times of stress and may help to maintain a healthy stress response.

Public Summary

Page 1 of

Produced at 26.11.2017 at 02:36:30 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

Chromium may assist in the maintenance of normal healthy blood sugar levels in healthy individuals.

Magnesium & taurine may assist in the maintenance of normal blood pressure in healthy individuals.

CardioX may help support / maintain / assist the health of the heart and cardiovascular system.

Folate, riboflavin and vitamin B12 may help support normal / healthy homocysteine levels.

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

Calcium amino acid chelate

36.89 mg/g

Calcium folinate

19.93 microgram/g

chromic chloride hexahydrate

63.08 microgram/g

Cyanocobalamin

.0246 mg/g

Magnesium amino acid chelate

368.89 mg/g

pyridoxal 5-phosphate

3.07 mg/g

Riboflavin sodium phosphate

307.5 microgram/g

Selenomethionine

15.37 microgram/g

Taurine

368.89 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 02:36:30 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