METAGENICS

Main information

Documents

Localization

  • Available in:
  • METAGENICS ADEK ESSENTIALS
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 215195
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

215195

METAGENICS ADEK ESSENTIALS

ARTG entry for

Medicine Listed

Sponsor

Health World Ltd

Postal Address

PO Box 675,VIRGINIA BC, QLD, 4014

Australia

ARTG Start Date

25/09/2013

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 ADEK ESSENTIALS

Product Type

Single Medicine Product

Effective date

25/09/2013

Warnings

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

for men.

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

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

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

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

Standard Indications

For vitamin (may state the vitamin) supplementation.

Vitamin D helps calcium absorption (or words of like intent) and a diet deficient in calcium can lead to osteoporosis in later life

Maintenance of healthy eyes.

Specific Indications

Vitamin A is required for maintenance of healthy skin.

Vitamins A and D are required for healthy immunity/a normal healthy immune system.

Vitamin D may reduce the risk of fractures, including hip fractures in the elderly.

Vitamins A, D and K are essential nutrients for normal healthy bones/bone density.

Vitamins D and K may help to support normal healthy cell function.

Vitamin K assists in the function of proteins important for bone development - is required for proper bone formation, by helping the body transport

calcium.

Vitamins K and E are required for cardiovascular health.

Vitamin E may support cardiovascular health and function.

Vitamins A and E are antioxidants and assist in providing protection against oxidative cellular damage.

Mixed tocopherols have been shown to be superior to alpha-tocopherol, as antioxidants.

Public Summary

Page 1 of

Produced at 26.11.2017 at 09:04:13 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

Tocotrienols may help to protect cellular DNA against free radical damage.

Tocotrienols are antioxidants and may help defend against free radical damage.

A significant number of Australians are at risk of vitamin D deficiency due to poor dietary intake and inadequate sun exposure.

Many elderly people, postmenopausal women and those with osteoporosis have low levels of Vitamin D.

Up to 31% of Australians are vitamin D deficient and up to 73% of Australians have insufficient levels.

The term vitamin E describes a family of eight isomers: four tocopherols (alpha-, beta-, gamma-, and delta-) and four tocotrienols.

Vitamin E is an essential nutrient for humans and therefore must be provided by foods and supplements. The eight isomers of vitamin E are found in

nature.

In those consuming low fat diets, the intake of fat-soluble vitamins (vitamins A, D, E and K) may be compromised.

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Capsule, soft

Route of Administration

Oral

Visual Identification

Active Ingredients

Betacarotene

2.751 mg

colecalciferol

.025 mg

mixed (low-alpha type) tocopherols concentrate

225.001 mg

palm tocotrienols complex

35 mg

Phytomenadione

1 mg

retinol palmitate

1.3744 mg

© 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 09:04:13 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

17-10-2018

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