Blooms Selenium Forte 150 mcg

Australia - English - Department of Health (Therapeutic Goods Administration)

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Active ingredient:
selenomethionine
Available from:
Phytologic Holdings Pty Ltd
INN (International Name):
Selenomethionine
Authorization status:
Listed
Authorization number:
293720

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Public Summary

Summary for ARTG Entry:

293720

Blooms Selenium Forte 150 mcg

ARTG entry for

Medicine Listed

Sponsor

Phytologic Holdings Pty Ltd

Postal Address

PO Box 6193,Alexandria, NSW, 2015

Australia

ARTG Start Date

11/09/2017

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. Blooms Selenium Forte 150 mcg

Product Type

Single Medicine Product

Effective date

11/09/2017

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.

Standard Indications

For mineral (may state the mineral) supplementation.

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

May assist in the prevention of mineral [XX] deficiency when dietary intake is inadequate

Specific Indications

Selenium is an antioxidant and helps protect the cells in the body from oxidative damage/the effects of free radicals.

Selenium plays an important role in the body's antioxidant systems.

Helps protect cells and tissues from free radical damage.

Selenium is an important component of the antioxidant enzyme glutathione peroxidase.

Selenium is a necessary component for the enzyme glutathione peroxidase.

Selenium is needed for testosterone synthesis.

Selenium is required for the health of the male reproductive system/for male reproductive health.

Selenium supports the health and function of the male reproductive system.

Maintains healthy immune function.

Healthy/normal selenium levels help support the health and function of the immune system

Selenium is essential for the enzymes that convert T4 to T3.

Selenium is necessary for the conversion of thyroid hormone T4 to T3. These hormones control a

range of normal biological and physiological processes in the body.

Selenium plays a role in the production of thyroid hormones, which are required for normal/healthy thyroid function.

Selenium supports normal/healthy thyroid function and thyroid hormone synthesis.

Helps maintain healthy heart function.

Helps maintain a normal/healthy cardiovascular system/heart.

Helps maintain healthy cardiovascular function.

Additional Product information

Public Summary

Page 1 of

Produced at 24.11.2017 at 06:10:18 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

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Capsule, hard

Route of Administration

Oral

Visual Identification

Active Ingredients

Selenomethionine

372.6 microgram

© 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 24.11.2017 at 06:10:18 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

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