ORTHOPLEX

Main information

Documents

Localization

  • Available in:
  • ORTHOPLEX MINERAL MATRIX WITH SELENIUM TABLETS
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217439
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217439

ORTHOPLEX MINERAL MATRIX WITH SELENIUM TABLETS

ARTG entry for

Medicine Listed

Sponsor

Bio Concepts Pty Ltd

Postal Address

PO Box 190,Banyo,Brisbane, QLD, 4014

Australia

ARTG Start Date

18/11/2013

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. ORTHOPLEX MINERAL MATRIX WITH SELENIUM TABLETS

Product Type

Single Medicine Product

Effective date

4/12/2015

Warnings

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

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).

Standard Indications

Maintain/support eye health

For vitamin (may state the vitamin) supplementation.

Male support. Balances and supports normal male physiology and function.

Maintain health of capillaries.

Protects capillaries.

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

Specific Indications

Supports the normal daily intake of vitamin C, chromium, iodine, manganese, molybdenum, selenium and zinc; For chromium, iodine, manganese,

molybdenum, selenium and zinc supplementation; Nutritional supplement; A multimineral supplement

Contains minerals that may help to support bone matrix

Vitamin C helps to maintain a normal/healthy cardiovascular system

Vitamin C is an important nutritional antioxidant/free radical scavenger; As an antioxidant, vitamin C assists in protecting the body from the damaging

effects of free radicals; Vitamin C is a potent antioxidant that can reduce the risk of cellular damage from free radicals; Vitamin C is also involved in the

normal/healthy regeneration of oxidised vitamin E in the body

Vitamin C is necessary for minor wound healing; Vitamin C is necessary for the maintenance of healthy skin; Assists in the normal/healthy healing and

repair of the skin

Vitamin C is involved in the normal breakdown of cholesterol into bile acids

Vitamin C is involved in normal/healthy carnitine synthesis

Public Summary

Page 1 of

Produced at 26.11.2017 at 06:19:41 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

Manganese is a non-specific cofactor for enzymes involved in normal/healthy carbohydrate and protein metabolism

Manganese is a non-specific cofactor for numerous enzymes

Iodine may help to support normal/healthy thyroid function; Iodine is required for the production of the thyroid hormones T4 and T3, which are important

for normal/healthy growth, thermogenesis and metabolism in all tissues

Chromium assists in the maintenance of a healthy cardiovascular system; Chromium supports the health of the cardiovascular system

Chromium is an essential nutrient required for carbohydrate, lipid and protein metabolism

Contains chromium, which is a main component of glucose tolerance factor

Chromium aids in the transport of glucose into the cells; Chromium facilitates the uptake of glucose into the cells; May assist with the uptake of glucose

into the cells

The human body needs to obtain vitamin C from outside sources as it cannot synthesise it itself

Vitamin C is involved in normal/healthy phenylalanine and tyrosine metabolism as well as norepinephrine synthesis

Contains zinc, which supports normal/healthy skin renewal processes

Contains zinc, which is involved in antioxidant processes and may therefore assist in protecting the body from the damaging effects of free radicals;

Contains zinc, which is a component of the antioxidant superoxide dismutase; Contains zinc, which has antioxidant activity and may therefore assist in

protecting the body from the damaging effects of free radicals; Zinc acts as a structural component of the antioxidant superoxide dismutase (SOD)

Contains zinc, which plays an important role in reproduction for both males and females

Contains zinc, which is involved in maintaining the structure and integrity of cell membranes; Contains zinc, which helps to maintain healthy skin

Contains zinc, which is involved in DNA, RNA and protein synthesis; Contains zinc, which plays a role in regulating gene expression; Contains zinc,

which plays a role in normal/healthy cell division; Contains zinc, which plays a role in regulating gene expression

Contains zinc, which helps support/maintain normal/healthy immune function; Contains zinc, which is important for the health and function of the immune

system

Contains zinc, which helps the body to metabolise proteins, carbohydrates and fats; Contains zinc, which plays an important role in the metabolism of

proteins, carbohydrates and fats

Zinc is an essential trace mineral that is a component in over 200 enzymes in the body

Selenium may help to maintain/support the health of the liver

Contains zinc, which binds to transcription factors to form zinc fingers. These fingers interact with specific DNA sequences to either enhance or repress

transcription; Zinc finger motifs stabilise the structure of a number of proteins and regulate gene expression by acting as transcription factors

Contains zinc, which supports healthy testosterone levels in men

Contains zinc, which supports the health and function of the nervous system

Contains zinc, which is essential for proper/normal/healthy growth and development

Contains zinc, which supports normal/healthy eye function; Contains zinc, which supports healthy vision and eye function; Zinc is important for healthy

eye function; Zinc plays an important role in the visual system

Selenium may assist in the maintenance of healthy heart function; May help to maintain a normal/healthy cardiovascular system/heart; Supports the

maintenance of healthy cardiovascular function

Contains selenium, which is an essential mineral in the selenium dependent enzyme that converts T4 to T3; Contains selenium, which is required for the

conversion of the thyroid hormone T4 to T3. These hormones control a variety of biological and physiological processes in the body; Selenium plays a

role in thyroid hormone production, which is required for normal thyroid function; Selenium supports normal/healthy thyroid function and thyroid hormone

synthesis

Selenium helps maintain healthy immune function; Selenium supports the health and function of the immune system

Selenium is required for testosterone synthesis; Selenium is required for the health of the reproductive system; Selenium supports normal sperm motility

in healthy men; Selenium supports the health and function of the male reproductive system; Selenium supports and maintains prostate health

Selenium is an antioxidant and therefore may assist in protecting the cells in the body from oxidative damage; Selenium has a role in the antioxidant

systems; Selenium assists in protecting cells and tissues from free radical damage; Selenium is an important part of the enzyme glutathione peroxidase,

and therefore is involved in the body's antioxidant systems; Selenium is a necessary component of the enzyme glutathione peroxidase, which neutralises

hydrogen peroxide in the body. Hydrogen peroxide is a compound that can cause oxidative damage to the cells of the body

Molybdenum is an essential ultratrace mineral that supports the normal/healthy metabolism of nucleotides, sulphite and sulphur-containing amino acids

Manganese is a cofactor for enzymes involved in normal/healthy cartilage and bone synthesis

Manganese is an important cofactor for manganese-superoxide dismutase, an important mitochondrial antioxidant enzyme

Vitamin C may be involved in the normal/healthy stabilisation and/or protection of folate against/from oxidation

Vitamin C is essential for the proper function of the immune system; Maintains a normal/healthy immune system; Supports the immune system by aiding

the activity of the white blood cells and antibody response; Vitamin C plays a vital role in many immune mechanisms; Vitamin C is involved in many

immune mechanisms in the body and supports healthy immune function; Vitamin C supports the healthy functioning of the immune system

Vitamin C is necessary for the manufacture of collagen in the body; Vitamin C plays a role in collagen formation; Vitamin C supports the development

and maintenance of bones; Vitamin C supports the development and maintenance of teeth; Vitamin C supports the development and maintenance of

cartilage; Vitamin C supports connective tissue formation

Vitamin C aids in the metabolism and synthesis of fats and proteins; Vitamin C aids iron absorption

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Tablet, uncoated

Route of Administration

Oral

Public Summary

Page 2 of

Produced at 26.11.2017 at 06:19:41 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

Visual Identification

Active Ingredients

calcium ascorbate

150 mg

Calcium citrate

99.53 mg

Chromium picolinate

402.25 microgram

Copper gluconate

461.54 microgram

Equisetum arvense

25 mg

Equivalent: Equisetum arvense (Dry)

100 mg

heavy magnesium oxide

33.16 mg

high molybdenum yeast

31 mg

Magnesium amino acid chelate

100 mg

Manganese amino acid chelate

15 mg

Potassium aspartate

100 mg

potassium iodide

196.2 microgram

sodium selenite

57.8 microgram

zinc amino acid chelate

25 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 3 of

Produced at 26.11.2017 at 06:19:41 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