ORTHOPLEX
Main information
- Trade name:
- ORTHOPLEX MINERAL MATRIX WITH SELENIUM TABLETS
- Available from:
- Bio Concepts Pty Ltd
- INN (International Name):
- calcium ascorbate,Calcium citrate,Chromium picolinate,Copper gluconate,Equisetum arvense,heavy magnesium oxide,high molybdenum y
- Medicine domain:
- Humans
- Medicine type:
- Allopathic drug
Documents
- for the general public:
- Public Assessment Report
-
- for the general public:
- The information leaflet for this product is not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain it.
Request the information leaflet for the general public.
- for healthcare professionals:
- The information leaflet for this product is not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain it.
Request the information leaflet for healthcare professionals.
Localization
- Available in:
-
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
- The information leaflet for this product is not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain it.
Request the information leaflet for the general public.
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18-12-2018

Calcium chloride / glutamic acid / glutathione / histidine / lactobionic acid / magnesium chloride / mannitol / potassium chloride / sodium hydroxide: List of nationally authorised medicinal products - PSUSA/00010390/201801
Calcium chloride / glutamic acid / glutathione / histidine / lactobionic acid / magnesium chloride / mannitol / potassium chloride / sodium hydroxide: List of nationally authorised medicinal products - PSUSA/00010390/201801
Europe - EMA - European Medicines Agency