BioTress

Main information

Documents

Localization

  • Available in:
  • BioTress
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217490
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217490

BioTress

ARTG entry for

Medicine Listed

Sponsor

Biomedica Nutraceuticals Pty Ltd

Postal Address

PO Box 7052,ALEXANDRIA, NSW, 2015

Australia

ARTG Start Date

19/11/2013

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. BioTress

Product Type

Single Medicine Product

Effective date

13/11/2015

Warnings

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

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

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

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

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.

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

for men.

Standard Indications

Maintain health of capillaries.

Source of vitamin B12. Can assist in maintaining normal blood.

Protects capillaries.

Beneficial during times of stress. [Warning S required]

Help reduce effects of mild anxiety and nervous tension. [Warning S required]

Helps relieve nervous unrest. [Warning S required]

For the relief of irritability. [Warning S required]

Helps relieve nervous tension, stress and mild anxiety. [Warning S required]

Source of vitamin B12. Can assist in maintaining normal blood. Blood tonic.

Source of folic acid. Can assist in maintaining normal blood. Blood tonic.

Source of folic acid. Can assist in maintaining normal blood.

Helps maintain normal blood/blood tonic (Note: These claims are appropriate for folic acid, vitamin B12 and iron, but must not imply anaemic conditions)

Relief of sleeplessness. [Warning S required]

Maintenance of healthy eyes.

Public Summary

Page 1 of

Produced at 23.11.2017 at 12:55:49 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

Prevention/treatment of vitamin [XX] and/or mineral [YY] and/or nutritional deficiencies (This indication is not be to used for the treatment of iron

deficiency conditions).

For vitamin (may state the vitamin) supplementation.

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

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

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

Specific Indications

Some of the B group vitamins such as vitamin B6 are involved in the manufacture and action hormones such as serotonin.

*Vitamin B1, B2, B3, B6, B12 support the healthy functioning of the nervous system/ Helps support the healthy functioning of the nervous system.

* Provides support to the nervous system.

* Provides vitamins to help maintain a healthy nervous system.

* Supports healthy nervous system function.

*Supports the synthesis of adrenal hormones.

*Supports neurotransmitter biosynthesis.

* Supports/maintains the health of the liver.

* Supports the health and function of the nervous system.

* Supports neuromuscular function.

* Contains nutrients that are involved in the production of energy in the body.

* Contains nutrients that play a vital role in the production of ATP, or cellular energy.

* Thiamine and pantothenic acid are involved in energy metabolism/the production of energy in the body.

* Helps the body convert food into energy.

* Supports healthy pregnancy.

* Provides nutritional support before and during pregnancy, when nutritional requirements are increased.

* Vitamin C is required in higher amounts during pregnancy.

* Contains essential vitamins and minerals that are required during pregnancy and whilst breastfeeding.

* Assists in maintaining health of the mother and the baby during pregnancy and lactation.

* Provides essential vitamins and minerals to support healthy growth and development of the baby.

* Contains essential nutrients for mother and baby.

* Supports the health of the mother and baby.

* Vitamin D is important for bone health.

* Vitamin D helps to maintain serum calcium and phosphorus levels, which is critical for the normal development of bones and teeth.

* Supports the development and maintenance of strong, healthy bones.

* Supports healthy bone mineral density.

* Vitamin D supports/helps maintain bone mineral density and helps to reduce the risk of fracture.

* Vitamin D and vitamin K help to maintain healthy bone mass and density.

* Vitamin D plays a role in calcium balance in the body.

* Vitamin D is mainly produced in our skin by a reaction that requires sunlight. People who limit their exposure to sunlight may have an increased need

for vitamin D supplementation.

* Provides a daily dose of 400 mcg of folinic and folic acid, which, if taken daily for one month before conception and during pregnancy, may reduce the

risk of having a child with spina bifida/neural tube defects.

* Folic acid plays a role in DNA synthesis. Folic acid is therefore essential for healthy cellular division and healthy foetal development.

* B vitamins work synergistically.

* Iodine is an important nutrient required for normal thyroid function.

* Iodine is important for the normal functioning of the thyroid gland as it is essential nutrient required for the synthesis of thyroid hormones.

* Supplies essential nutrients to help meet normal daily requirements.

* Assists in the maintenance of a normal/healthy cardiovascular system.

* Contains nutrients that help maintain cardiovascular health.

* A source of pyridoxine, folic acid and cyanocobalamin. Low plasma levels of these vitamins has been associated with high blood levels of

homocysteine, a biologic marker associated with an increased risk of reduced or diminished well being.

* Contains vitamin C, riboflavin, pantothenic acid, pyridoxine, cyanocobalamin, vitamin E, vitamin A, selenium and zinc which are essential for the proper

function of the immune system.

* Maintains a normal/healthy immune system.

* Vitamin C, riboflavin, pantothenic acid, pyridoxine, cyanocobalamin, vitamin E, vitamin A, selenium and zinc supports the immune system by aiding the

activity of the white blood cells and antibody response.

* Vitamin C, riboflavin, pantothenic acid, pyridoxine, cyanocobalamin, vitamin E, vitamin A, selenium and zinc play a vital role in many immune

mechanisms.

* Contains nutrients that are involved in many immune mechanisms in the body and that support healthy immune function.

* Vitamin D supports the health and function of the immune system.

* Vitamin C, riboflavin, niacin, vitamin E, selenium and zinc are important nutritional antioxidants/free radical scavengers.

* As antioxidants, vitamin C, vitamin E, riboflavin, niacin, selenium and zinc assist in protecting the body from the damaging effects of free radicals.

* Vitamin C, riboflavin, niacin, vitamin E, and selenium and zinc are potent antioxidants that can reduce the risk of cellular damage from free radicals.

* Contains important nutritional antioxidants and can therefore assist in protecting against potential free radical/oxidative damage.

* May help reduce the oxidation of LDL cholesterol.

* Antioxidant, or free radical scavenger.

* Assists in protecting the cells of the body from free radical damage.

* Vitamin C, riboflavin, pantothenic acid, vitamin E, Vitamin A and zinc are necessary for wound healing.

* Vitamin C, riboflavin, pantothenic acid, pyridoxine, Vitamin E, Vitamin A and zinc are necessary for the maintenance of healthy skin.

* Assists in the healing and repair of the skin.

* Supports healthy skin.

* May help reduce the oxidation of LDL cholesterol.

* Contains selenium, cyanocobalamin, vitamin A, and zinc, which are required for the health of the reproductive system.

* Contains selenium, cyanocobalamin and zinc, which support normal sperm motility. In healthy men.

* Contains selenium, cyanocobalamin, vitamin A, and zinc which support the health and function of the male reproductive system.

* Contains selenium which support and maintain prostate health.

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

*Zinc is necessary for the proper action of many body hormones including sex hormones.

* Zinc supports the health of the female and male reproductive system.

* zinc and vitamin B6 support healthy hormonal balance.

*For zinc supplementation

* Contains pantothenic acid, which is required for proper function of the adrenal gland.

* Pantothenic acid supports the adrenal glands in the making of cortisone and other adrenal hormones that counteract the stress response.

Public Summary

Page 2 of

Produced at 23.11.2017 at 12:55:49 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

* Helps calm the nerves.

*Contains nutrients which may assist in reducing the effects of nervous tension, stress and mild anxiety.

*Provides support to the nervous system.

*Supports healthy nervous system function.

* Supports the health and function of the nervous system.

* Pantothenic acid is utilized in the manufacture of adrenal hormones.

* Pantothenic acid is necessary for proper adrenal function/function of the adrenal glands.

* Pantothenic acid supports the adrenal glands in the making of cortisone and other adrenal hormones that counteract the stress response.

* The human body has increased requirements for the vitamins (especially the B group) and minerals during of stress.

* During stress, nutrients such as vitamin B6, vitamin B5 are important for supporting adrenal function.

* Vitamin B5 has long been considered the "anti-stress" vitamin because of its central role in adrenal function and cellular metabolism

*Calcium folinate is a ready source of folinic acid.

* Folinic acid quickly converts to the most active form of folate.

*Calcium Folinate has been shown to raise plasma folate more effectively than folic acid.,

* Biotin functions in the human body as an essential co-factor for enzymes which are involved in the metabolism of carbohydrates, fats and proteins.

* Pantothenic acid, biotin, riboflavin and cyanocobalamin are involved in the metabolism of protein, or amino acids in the body.

* Thiamine, pantothenic acid, riboflavin and cyanocobalamin are involved in the metabolism of carbohydrates in the body.

* B vitamins in this formula participate in many biochemical reactions in the body, including the conversion of foods into energy and the regulation of

metabolism.

* Chromium is an essential trace element for normal carbohydrate metabolism.

* Supports/maintains healthy brain function.

* Supports cognitive function and memory.

* Contains nutrients necessary for healthy brain function.

* Supports healthy sleep patterns.

* May assist sleep.

*Contains chromium which plays an important role in blood sugar control mechanisms.

*Chromium is a key constituent of GTF (glucose tolerance factor), which facilitates the uptake of glucose by the cells.

* Supports the body's detoxification mechanisms.

* Taurine, Choline, inositol, pyridoxine, folic acid & cyanocobalamin are involved in the phase two liver detoxification pathway.

* Supports red blood cell health.

* Vitamin C improves iron absorption.

* Folic acid can assist in maintaining normal blood.

* Folic acid is one of the nutrients necessary for the production of normal red blood cells.

* Contains nutrients that can assist in maintaining normal blood. Blood tonic.

*Riboflavin functions as a component of important enzymes that are involved in energy production.

*Riboflavin is crucial in the production of energy in the body.

*Pantothenic acid plays a critical role in energy production.

*Provides nutrients that are essential in the body for the production of energy.

*Contains nutrients that assist in energy metabolism in the body.

* Contains nutrients that are involved in protein, carbohydrate and fat metabolism in the body.

* Contains nutrients that are essential for carbohydrate, protein and fat metabolism.

*Provides essential B group vitamins required for energy production.

* B complex vitamins are needed for the metabolism of food into energy.

* Supports healthy metabolism of proteins, carbohydrates and fats in the body.

* Vitamin B6 assists in the metabolism protein/amino acids and fats.

*Thiamine, pantothenic acid, riboflavin, biotin and cyanocobalamin are involved in the metabolism of carbohydrates in the body

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Capsule, hard

Route of Administration

Oral

Visual Identification

Active Ingredients

Ascorbic acid

100 mg

Biotin

50 microgram

Calcium folinate

136.36 microgram

Calcium pantothenate

75 mg

Calcium phosphate

13.7 mg

Choline bitartrate

25 mg

Chromium picolinate

201.13 microgram

Citrus bioflavonoids extract

12.5 mg

colecalciferol

5 microgram

colloidal anhydrous silica

12.83 mg

Copper gluconate

92.86 microgram

Cyanocobalamin

200 microgram

cysteine hydrochloride

25 mg

d-alpha-Tocopheryl acid succinate

41.32 mg

Public Summary

Page 3 of

Produced at 23.11.2017 at 12:55:49 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

dibasic potassium phosphate

10.02 mg

Folic acid

95 microgram

Fucus vesiculosus

10 mg

Equivalent: Fucus vesiculosus (Dry)

50 mg

Glutamine

25 mg

Glycine

25 mg

Hesperidin

7.5 mg

Inositol

12.5 mg

Lysine hydrochloride

15.62 mg

Magnesium amino acid chelate

50 mg

Manganese amino acid chelate

5 mg

molybdenum trioxide

75 microgram

Nicotinamide

107.5 mg

Nicotinic acid

2.5 mg

Peppermint Oil

1 mg

Phytomenadione

.05 mg

potassium iodide

85 microgram

pyridoxal 5-phosphate monohydrate

10.74 mg

pyridoxine hydrochloride

10 mg

retinol acetate

.1771 mg

Riboflavin

15 mg

rutoside

2.5 mg

Selenomethionine

62.5 microgram

Taurine

25 mg

Thiamine hydrochloride

37.5 mg

zinc citrate dihydrate

23.36 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 4 of

Produced at 23.11.2017 at 12:55:49 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